Project: Every Child for Younger Patients With Cancer

Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT02402244
Collaborator
National Cancer Institute (NCI) (NIH)
33,000
240
122.2
137.5
1.1

Study Details

Study Description

Brief Summary

This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Detailed Description

PRIMARY OBJECTIVES:
  1. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

  2. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

  3. To develop a well annotated childhood cancer biorespository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline deoxyribonucleic acid (DNA); and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions.

  4. To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.

OUTLINE:

Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, saliva, cerebrospinal fluid, or urine).

Study Design

Study Type:
Observational
Anticipated Enrollment :
33000 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
Actual Study Start Date :
Oct 26, 2015
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Observational (Project: Every Child)

Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of biospecimen samples (e.g., tissue, blood, bone marrow, plasma, serum, saliva, cerebrospinal fluid, or urine).

Other: Cytology Specimen Collection Procedure
Undergo cytology specimen collection

Other: Medical Chart Review
Undergo medical data review

Outcome Measures

Primary Outcome Measures

  1. Number of patients who consented to biobanking [Baseline]

    The number of patients who agree to be in the Biobanking part of the study and have leftover tumor tissue and some normal blood, bone marrow, or other tissue saved for future research.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem

  • Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority

  • Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:

  • All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant)

  • All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant

  • The following other benign/borderline conditions:

  • Mesoblastic nephroma

  • Teratomas (mature and immature types)

  • Myeloproliferative diseases including transient myeloproliferative disease

  • Langerhans cell histiocytosis

  • Lymphoproliferative diseases

  • Desmoid tumors

  • Gonadal stromal cell tumors

  • Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit

  • All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission

  • If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Alabama Birmingham Alabama United States 35233
2 USA Health Strada Patient Care Center Mobile Alabama United States 36604
3 Providence Alaska Medical Center Anchorage Alaska United States 99508
4 Banner Children's at Desert Mesa Arizona United States 85202
5 Phoenix Childrens Hospital Phoenix Arizona United States 85016
6 Banner University Medical Center - Tucson Tucson Arizona United States 85719
7 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
8 Kaiser Permanente Downey Medical Center Downey California United States 90242
9 City of Hope Comprehensive Cancer Center Duarte California United States 91010
10 Loma Linda University Medical Center Loma Linda California United States 92354
11 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
12 Children's Hospital Los Angeles Los Angeles California United States 90027
13 Cedars Sinai Medical Center Los Angeles California United States 90048
14 Mattel Children's Hospital UCLA Los Angeles California United States 90095
15 Valley Children's Hospital Madera California United States 93636
16 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
17 Kaiser Permanente-Oakland Oakland California United States 94611
18 Children's Hospital of Orange County Orange California United States 92868
19 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
20 Sutter Medical Center Sacramento Sacramento California United States 95816
21 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
22 Rady Children's Hospital - San Diego San Diego California United States 92123
23 Naval Medical Center -San Diego San Diego California United States 92134
24 UCSF Medical Center-Mission Bay San Francisco California United States 94158
25 Santa Barbara Cottage Hospital Santa Barbara California United States 93102
26 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
27 Children's Hospital Colorado Aurora Colorado United States 80045
28 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado United States 80218
29 Connecticut Children's Medical Center Hartford Connecticut United States 06106
30 Yale University New Haven Connecticut United States 06520
31 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
32 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
33 Children's National Medical Center Washington District of Columbia United States 20010
34 Broward Health Medical Center Fort Lauderdale Florida United States 33316
35 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
36 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
37 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
38 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
39 Palms West Radiation Therapy Loxahatchee Groves Florida United States 33470
40 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
41 Nicklaus Children's Hospital Miami Florida United States 33155
42 Miami Cancer Institute Miami Florida United States 33176
43 AdventHealth Orlando Orlando Florida United States 32803
44 Arnold Palmer Hospital for Children Orlando Florida United States 32806
45 Nemours Children's Hospital Orlando Florida United States 32827
46 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
47 Sacred Heart Hospital Pensacola Florida United States 32504
48 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
49 Tampa General Hospital Tampa Florida United States 33606
50 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
51 Saint Mary's Hospital West Palm Beach Florida United States 33407
52 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
53 Augusta University Medical Center Augusta Georgia United States 30912
54 Medical Center of Central Georgia Macon Georgia United States 31201
55 Memorial Health University Medical Center Savannah Georgia United States 31404
56 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
57 Tripler Army Medical Center Honolulu Hawaii United States 96859
58 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
59 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
60 University of Illinois Chicago Illinois United States 60612
61 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
62 Loyola University Medical Center Maywood Illinois United States 60153
63 Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois United States 60453
64 Advocate Children's Hospital-Park Ridge Park Ridge Illinois United States 60068
65 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
66 Southern Illinois University School of Medicine Springfield Illinois United States 62702
67 Riley Hospital for Children Indianapolis Indiana United States 46202
68 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
69 Blank Children's Hospital Des Moines Iowa United States 50309
70 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
71 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
72 Norton Children's Hospital Louisville Kentucky United States 40202
73 Children's Hospital New Orleans New Orleans Louisiana United States 70118
74 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
75 Eastern Maine Medical Center Bangor Maine United States 04401
76 Maine Children's Cancer Program Scarborough Maine United States 04074
77 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
78 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
79 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
80 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
81 Tufts Children's Hospital Boston Massachusetts United States 02111
82 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
83 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
84 Baystate Medical Center Springfield Massachusetts United States 01199
85 UMass Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
86 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
87 Children's Hospital of Michigan Detroit Michigan United States 48201
88 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
89 Ascension Saint John Hospital Detroit Michigan United States 48236
90 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
91 Hurley Medical Center Flint Michigan United States 48503
92 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
93 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
94 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
95 West Michigan Cancer Center Kalamazoo Michigan United States 49007
96 Beaumont Children's Hospital-Royal Oak Royal Oak Michigan United States 48073
97 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
98 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
99 Mayo Clinic in Rochester Rochester Minnesota United States 55905
100 University of Mississippi Medical Center Jackson Mississippi United States 39216
101 Columbia Regional Columbia Missouri United States 65201
102 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
103 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
104 Washington University School of Medicine Saint Louis Missouri United States 63110
105 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
106 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
107 University of Nebraska Medical Center Omaha Nebraska United States 68198
108 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
109 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
110 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
111 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
112 Renown Regional Medical Center Reno Nevada United States 89502
113 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
114 Hackensack University Medical Center Hackensack New Jersey United States 07601
115 Morristown Medical Center Morristown New Jersey United States 07960
116 Jersey Shore Medical Center Neptune New Jersey United States 07753
117 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
118 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
119 Newark Beth Israel Medical Center Newark New Jersey United States 07112
120 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
121 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
122 Presbyterian Hospital Albuquerque New Mexico United States 87106
123 Albany Medical Center Albany New York United States 12208
124 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
125 Maimonides Medical Center Brooklyn New York United States 11219
126 Roswell Park Cancer Institute Buffalo New York United States 14263
127 NYU Winthrop Hospital Mineola New York United States 11501
128 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
129 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
130 Mount Sinai Hospital New York New York United States 10029
131 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
132 Memorial Sloan Kettering Cancer Center New York New York United States 10065
133 NYP/Weill Cornell Medical Center New York New York United States 10065
134 University of Rochester Rochester New York United States 14642
135 Stony Brook University Medical Center Stony Brook New York United States 11794
136 State University of New York Upstate Medical University Syracuse New York United States 13210
137 New York Medical College Valhalla New York United States 10595
138 Mission Hospital Asheville North Carolina United States 28801
139 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
140 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
141 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
142 Duke University Medical Center Durham North Carolina United States 27710
143 East Carolina University Greenville North Carolina United States 27834
144 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
145 Sanford Broadway Medical Center Fargo North Dakota United States 58122
146 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
147 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
148 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
149 Cleveland Clinic Foundation Cleveland Ohio United States 44195
150 Nationwide Children's Hospital Columbus Ohio United States 43205
151 Dayton Children's Hospital Dayton Ohio United States 45404
152 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
153 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
154 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
155 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
156 Oregon Health and Science University Portland Oregon United States 97239
157 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
158 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
159 Geisinger Medical Center Danville Pennsylvania United States 17822
160 Penn State Children's Hospital Hershey Pennsylvania United States 17033
161 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
162 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
163 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
164 Rhode Island Hospital Providence Rhode Island United States 02903
165 Medical University of South Carolina Charleston South Carolina United States 29425
166 Prisma Health Richland Hospital Columbia South Carolina United States 29203
167 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
168 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
169 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
170 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
171 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105
172 The Children's Hospital at TriStar Centennial Nashville Tennessee United States 37203
173 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
174 Texas Tech University Health Sciences Center-Amarillo Amarillo Texas United States 79106
175 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
176 Driscoll Children's Hospital Corpus Christi Texas United States 78411
177 Medical City Dallas Hospital Dallas Texas United States 75230
178 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
179 El Paso Children's Hospital El Paso Texas United States 79905
180 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
181 Cook Children's Medical Center Fort Worth Texas United States 76104
182 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
183 M D Anderson Cancer Center Houston Texas United States 77030
184 Covenant Children's Hospital Lubbock Texas United States 79410
185 UMC Cancer Center / UMC Health System Lubbock Texas United States 79415
186 Vannie Cook Children's Clinic McAllen Texas United States 78503
187 Children's Hospital of San Antonio San Antonio Texas United States 78207
188 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
189 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
190 Scott and White Memorial Hospital Temple Texas United States 76508
191 Primary Children's Hospital Salt Lake City Utah United States 84113
192 University of Vermont and State Agricultural College Burlington Vermont United States 05405
193 University of Virginia Cancer Center Charlottesville Virginia United States 22908
194 Inova Fairfax Hospital Falls Church Virginia United States 22042
195 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
196 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
197 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
198 Carilion Children's Roanoke Virginia United States 24014
199 Seattle Children's Hospital Seattle Washington United States 98105
200 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
201 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
202 Madigan Army Medical Center Tacoma Washington United States 98431
203 West Virginia University Charleston Division Charleston West Virginia United States 25304
204 West Virginia University Healthcare Morgantown West Virginia United States 26506
205 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
206 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
207 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
208 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
209 John Hunter Children's Hospital Hunter Regional Mail Centre New South Wales Australia 2310
210 Sydney Children's Hospital Randwick New South Wales Australia 2031
211 The Children's Hospital at Westmead Westmead New South Wales Australia 2145
212 Queensland Children's Hospital South Brisbane Queensland Australia 4101
213 Women's and Children's Hospital-Adelaide North Adelaide South Australia Australia 5006
214 Monash Medical Center-Clayton Campus Clayton Victoria Australia 3168
215 Royal Children's Hospital Parkville Victoria Australia 3052
216 Princess Margaret Hospital for Children Perth Western Australia Australia 6008
217 Perth Children's Hospital Perth Western Australia Australia 6009
218 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
219 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
220 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
221 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
222 Janeway Child Health Centre Saint John's Newfoundland and Labrador Canada A1B 3V6
223 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
224 McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
225 Kingston Health Sciences Centre Kingston Ontario Canada K7L 2V7
226 Children's Hospital London Ontario Canada N6A 5W9
227 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
228 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
229 The Montreal Children's Hospital of the MUHC Montreal Quebec Canada H3H 1P3
230 Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec Canada H3T 1C5
231 Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Quebec Canada J1H 5N4
232 Jim Pattison Children's Hospital Saskatoon Saskatchewan Canada S7N 0W8
233 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4
234 Centre Hospitalier Universitaire de Quebec Quebec Canada G1V 4G2
235 Starship Children's Hospital Grafton Auckland New Zealand 1145
236 Christchurch Hospital Christchurch New Zealand 8011
237 HIMA San Pablo Oncologic Hospital Caguas Puerto Rico 00726
238 San Jorge Children's Hospital San Juan Puerto Rico 00912
239 University Pediatric Hospital San Juan Puerto Rico 00926
240 King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia 11211

Sponsors and Collaborators

  • Children's Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Douglas Hawkins, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT02402244
Other Study ID Numbers:
  • APEC14B1
  • NCI-2014-02057
  • APEC14B1
  • APEC14B1
  • U10CA098543
First Posted:
Mar 30, 2015
Last Update Posted:
Aug 18, 2022
Last Verified:
Feb 1, 2022

Study Results

No Results Posted as of Aug 18, 2022