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Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT00736749
Collaborator
National Cancer Institute (NCI) (NIH)
4,738
Enrollment
164
Locations
28.9
Patients Per Site

Study Details

Study Description

Brief Summary

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Assessment of Therapy Complications
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

  1. To develop a mechanism for tracking and retaining patients enrolled on Children's Oncology Group (COG) protocols.

  2. To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status.

  3. To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols targeted for follow-up by the Long-Term Follow-Up Center (LTFC).

  4. To provide current patient contact information and self/parent-reported health status updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution.

  5. To facilitate collection of protocol-specific outcome data through collaboration with the LTFC Oversight Committee, the SDC, and the member institutions.

OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.

Within 3 months of enrollment on ALTE05N1, patients receive a mailed packet introducing the Long-Term Follow-Up Center (LTFC). Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.

Study Design

Study Type:
Observational
Anticipated Enrollment :
4738 participants
Official Title:
Umbrella Long-Term Follow-Up Protocol
Actual Study Start Date :
May 19, 2008
Anticipated Primary Completion Date :
Jan 31, 2100

Arms and Interventions

Arm Intervention/Treatment
Observational (long-term follow-up)

Within 3 months of enrollment of ALTE05N1, patients receive a mailed packet introducing the LTFC. Patients are asked to complete a patient response form, verify information provided in packet, and update contact and health status information. The Health Status Update Form is a brief document including questions about current health status, disease status, and cancer therapy received since the last mailing. Patients may respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone number.

Procedure: Assessment of Therapy Complications
Complete patient response form and Health Status Update Form

Other: Questionnaire Administration
Complete patient response form and Health Status Update Form

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients enrolled [Up to 20 years]

  2. Percentage of patients in which long-term (20+ years) contact is maintained [Up to 20 years]

  3. Percentage of eligible patients located who were lost to follow-up [Up to 20 years]

  4. Percentage of located patients enrolled [Up to 20 years]

    Differences between participants and non-participants will be examined annually, in terms of demographic (age, sex, ethnicity) and clinical characteristics (primary diagnosis, therapeutic protocol, time since diagnosis, treating institution).

  5. Collection of protocol-specific outcome data [Up to 20 years]

    Methods of statistical analysis to be used are those appropriate for analysis of cohort studies. Poisson regression (piece-wise exponential models) and Cox regression will be the primary methods of risk-factor analysis. When comparing study cohort with national rates, Poisson regression will be used. When the comparison is internal (ie, no use of national standard rates), Cox regression will be used.

  6. Collection of cumulative therapeutic exposure data [Up to 20 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • The patient must be enrolled on a frontline COG therapeutic trial for treatment of a primary malignancy;or the patient must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial targeted for long-term follow-up by ALTE05N1

  • Hodgkin lymphoma

  • CCG 5942

  • POG 9425

  • POG 9426

  • AHOD0031

  • AHOD1331

  • S1826 (COG patients only)

  • Brain tumor

  • A9961

  • Acute lymphoblastic leukemia

  • POG 9404

  • Osteosarcoma

  • POG 9754

  • Stem cell transplantation

  • ASCT0631D

  • Rhabdomyosarcoma

  • IRS-III

  • IRS-IV

  • Late Effects Protocols with Patients Eligible for Enrollment on ALTE05N1

  • ALTE15N1

  • ALTE16C1

  • Enrollment on ALTE05N1 must occur within 24 calendar months of the date the patient was enrolled on a frontline COG therapeutic trial; or patients previously enrolled on a COG (or Legacy Group) trial targeted for long term follow-up by ALTE05N1 may enroll on ALTE05N1 at any time

  • The patient must reside in the U.S. on the date of enrollment to ALTE05N1

  • All patients and/or their parents or legal guardians must sign a written informed consent

  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Alabama Birmingham Alabama United States 35233
2 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
3 USA Health Strada Patient Care Center Mobile Alabama United States 36604
4 Phoenix Childrens Hospital Phoenix Arizona United States 85016
5 The University of Arizona Medical Center-University Campus Tucson Arizona United States 85724
6 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
7 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
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 Kaiser Permanente-Oakland Oakland California United States 94611
17 Children's Hospital of Orange County Orange California United States 92868
18 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
19 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
20 Rady Children's Hospital - San Diego San Diego California United States 92123
21 UCSF Medical Center-Parnassus San Francisco California United States 94143
22 UCSF Medical Center-Mission Bay San Francisco California United States 94158
23 Children's Hospital Colorado Aurora Colorado United States 80045
24 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado United States 80218
25 Connecticut Children's Medical Center Hartford Connecticut United States 06106
26 Yale University New Haven Connecticut United States 06520
27 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
28 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
29 Children's National Medical Center Washington District of Columbia United States 20010
30 Broward Health Medical Center Fort Lauderdale Florida United States 33316
31 Lee Memorial Health System Fort Myers Florida United States 33901
32 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
33 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
34 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
35 Miami Cancer Institute Miami Florida United States 33176
36 Florida Hospital Orlando Orlando Florida United States 32803
37 Arnold Palmer Hospital for Children Orlando Florida United States 32806
38 Nemours Children's Clinic - Orlando Orlando Florida United States 32806
39 UF Cancer Center at Orlando Health Orlando Florida United States 32806
40 Nemours Children's Hospital Orlando Florida United States 32827
41 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
42 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
43 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
44 Saint Mary's Hospital West Palm Beach Florida United States 33407
45 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
46 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
47 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
48 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
49 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
50 University of Illinois Chicago Illinois United States 60612
51 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
52 Loyola University Medical Center Maywood Illinois United States 60153
53 Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois United States 60453
54 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
55 Southern Illinois University School of Medicine Springfield Illinois United States 62702
56 Riley Hospital for Children Indianapolis Indiana United States 46202
57 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
58 Blank Children's Hospital Des Moines Iowa United States 50309
59 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
60 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
61 Norton Children's Hospital Louisville Kentucky United States 40202
62 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
63 Children's Hospital New Orleans New Orleans Louisiana United States 70118
64 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
65 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
66 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
67 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
68 Floating Hospital for Children at Tufts Medical Center Boston Massachusetts United States 02111
69 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
70 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
71 Ascension Saint John Hospital Detroit Michigan United States 48236
72 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
73 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
74 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
75 Mayo Clinic Rochester Minnesota United States 55905
76 University of Mississippi Medical Center Jackson Mississippi United States 39216
77 Columbia Regional Columbia Missouri United States 65201
78 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
79 Washington University School of Medicine Saint Louis Missouri United States 63110
80 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
81 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
82 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
83 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
84 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
85 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
86 Hackensack University Medical Center Hackensack New Jersey United States 07601
87 Morristown Medical Center Morristown New Jersey United States 07960
88 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
89 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
90 Newark Beth Israel Medical Center Newark New Jersey United States 07112
91 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
92 Overlook Hospital Summit New Jersey United States 07902
93 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
94 Albany Medical Center Albany New York United States 12208
95 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
96 Roswell Park Cancer Institute Buffalo New York United States 14263
97 NYU Winthrop Hospital Mineola New York United States 11501
98 Mount Sinai Hospital New York New York United States 10029
99 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
100 University of Rochester Rochester New York United States 14642
101 Stony Brook University Medical Center Stony Brook New York United States 11794
102 State University of New York Upstate Medical University Syracuse New York United States 13210
103 New York Medical College Valhalla New York United States 10595
104 Mission Hospital Inc-Memorial Campus Asheville North Carolina United States 28801
105 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
106 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
107 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
108 Duke University Medical Center Durham North Carolina United States 27710
109 East Carolina University Greenville North Carolina United States 27834
110 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
111 Sanford Broadway Medical Center Fargo North Dakota United States 58122
112 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
113 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
114 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
115 Cleveland Clinic Foundation Cleveland Ohio United States 44195
116 Nationwide Children's Hospital Columbus Ohio United States 43205
117 Dayton Children's Hospital Dayton Ohio United States 45404
118 The Toledo Hospital/Toledo Children's Hospital Toledo Ohio United States 43606
119 Mercy Children's Hospital Toledo Ohio United States 43608
120 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
121 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
122 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
123 Oregon Health and Science University Portland Oregon United States 97239
124 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
125 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
126 Penn State Children's Hospital Hershey Pennsylvania United States 17033
127 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
128 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
129 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
130 Rhode Island Hospital Providence Rhode Island United States 02903
131 Medical University of South Carolina Charleston South Carolina United States 29425
132 Prisma Health Richland Hospital Columbia South Carolina United States 29203
133 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
134 Greenville Cancer Treatment Center Greenville South Carolina United States 29605
135 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
136 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
137 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
138 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
139 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
140 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
141 Driscoll Children's Hospital Corpus Christi Texas United States 78411
142 Medical City Dallas Hospital Dallas Texas United States 75230
143 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
144 Cook Children's Medical Center Fort Worth Texas United States 76104
145 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
146 Children's Hospital of San Antonio San Antonio Texas United States 78207
147 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
148 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
149 Primary Children's Hospital Salt Lake City Utah United States 84113
150 University of Vermont and State Agricultural College Burlington Vermont United States 05405
151 Inova Fairfax Hospital Falls Church Virginia United States 22042
152 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
153 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
154 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
155 Seattle Children's Hospital Seattle Washington United States 98105
156 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
157 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
158 Madigan Army Medical Center Tacoma Washington United States 98431
159 West Virginia University Charleston Division Charleston West Virginia United States 25304
160 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
161 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
162 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
163 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
164 San Jorge Children's Hospital San Juan Puerto Rico 00912

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Smita Bhatia, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00736749
Other Study ID Numbers:
  • ALTE05N1
  • NCI-2009-00382
  • PALTE05N1_A06PAMDREVW01
  • CDR0000590123
  • ALTE05N1
  • ALTE05N1
  • U10CA180886
  • U10CA098543
  • UG1CA189955
  • UG1CA189958
First Posted:
Aug 18, 2008
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Osteosarcoma
Rhabdomyosarcoma
Brain Neoplasms

Study Results

No Results Posted as of Sep 13, 2021