Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Active, not recruiting

CT.gov ID

NCT03707574

Collaborator

(none)

150

Enrollment

144

Locations

48.7

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial studies the genetic analysis of blood and tissue samples from patients with cancer that has spread to other anatomic sites (advanced) or is no longer responding to treatment. Studying these samples in the laboratory may help doctors to learn how genes affect cancer and how they affect a person's response to treatment.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignant Neoplasm Advanced Melanoma Advanced Renal Cell Carcinoma Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8	Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVES:

To procure paired newly acquired tumor tissues and blood at baseline and upon progression in patients treated for advanced cancer with molecularly targeted therapies at National Cancer Institute Community Oncology Research Program (NCORP) sites.
To bank formalin-fixed, paraffin-embedded (FFPE) tissue, blood (for cell-free deoxyribonucleic acid [DNA] analysis), and nucleic acids from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.
To bank, when available, optional snap-frozen tissue (for future to be determined analysis) from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.
To assess the feasibility of obtaining paired high-quality newly acquired tumor tissues and blood from patients being treated for advanced cancer in community-based healthcare settings (NCORP sites).

SECONDARY OBJECTIVES:

To perform molecular profiling assays on matched malignant tumor and blood (including but not limited to whole exome and messenger ribonucleic acid [RNA] sequencing) in order to provide physicians and patients with a clinical report from a Clinical Laboratory Improvement Act (CLIA)-certified laboratory from tumor obtained at baseline and upon progression that may be used to guide further treatment planning.
To make available biospecimens for studies to define potential resistance biomarkers using genomic and proteomic-based assessment platforms.
To contribute genetic analysis data from coded specimens to Genomic Data Commons, a well annotated cancer molecular and clinical data repository, for current and future research; specimens will be annotated with key clinical data including presentation, diagnosis, staging, summary treatment, and outcome, if possible.
To identify potential predictive and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned.
To identify resistance mechanisms using genomic DNA- and RNA-based assessment platforms.

OUTLINE:

Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an objective response [OR] or stable disease [SD] after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

NCORP Tissue Procurement Protocol: An NCI Cancer Moonshot Study

Actual Study Start Date :

Apr 9, 2019

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Ancillary-correlative (genetic analysis) Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an OR or SD after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.	Procedure: Biospecimen Collection Undergo collection of blood and tissue Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection

Arm

Intervention/Treatment

Ancillary-correlative (genetic analysis)

Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an OR or SD after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.

Procedure: Biospecimen Collection

Undergo collection of blood and tissue

Other Names:

Biological Sample Collection

Biospecimen Collected

Specimen Collection

Outcome Measures

Primary Outcome Measures

Obtaining tumor tissue and blood specimens [Up to 2 years]
Will obtain tumor tissue and blood specimens for biobanking and to store tissues, blood, and nucleic acids for future research, including the study of matched pre and post-treatment tumor biopsies to elucidate mechanisms of resistance. Cases will be grouped according to histology and/or treatment.

Secondary Outcome Measures

Tumor tissues storage in the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH) (Biorepository) [Up to 2 years]
Genomic analysis [Up to 2 years]
Will perform genomic studies, including a pan-cancer gene panel, and contribute molecular data to the genomic data commons.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient meets all eligibility criteria for treatment of the tumors with the agents listed and has agreed to provide tissue and blood samples for this study
Targeted therapy maybe as a singular/monotherapy or in combination with any Food and Drug Administration (FDA)-approved chemotherapies
Patient's primary or recurrent disease is targeted-treatment naive or will be treated with a targeted therapy listed different from any previously-received targeted therapy or combination therapy as standard of care
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Patients with a PS of 2 may be enrolled only at the discretion of the treating physician and radiologist
Have an advanced malignancy being treated with one of the agents listed. Advanced cancer is cancer that is unlikely to be cured or controlled with treatment. The cancer may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Treatment may be given to help shrink the tumor, slow the growth of cancer cells, or relieve symptoms. Patients may be undergoing first or subsequent lines of therapy. In the case where an agent not listed is newly approved for one of the listed tumors, patients undergoing therapy with it will be able to enroll at discretion of the principal investigator (PI). This is to avoid any lag between FDA approval of a previously investigational agent and protocol modifications/updates
Have an advanced malignancy that meets one of the following criteria:
Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. The biopsy must not be associated with a significant risk of severe or major complications or death. In particular, endoscopic, open or laparoscopic surgical procedures are not to be performed to provide research specimens. However, research specimens may be provided if the patient needs to undergo such procedures for clinical reasons
Severe or major complications are considered to be those
Requiring therapy, minor hospitalization (more than overnight but < 48 hours [h])
Requiring major therapy; unplanned increase in level of care, prolonged hospitalization > 48 h
Resulting in permanent adverse sequelae
Resulting in death
Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected. The following tumors may be collected only under the conditions specified and not for the sole purpose of the clinical trial:
Brain biopsies: ONLY if the patient has medical necessity for craniotomy for clinical care
Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies: ONLY to be obtained incidentally to a clinically necessary procedure

Exclusion Criteria:

Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
Patients currently enrolled or planning to be co-enrolled (while participating on the 10231 study) on a therapeutically interventional clinical trial aimed to treat the current malignancy
If the patient is on chronic anticoagulation treatment, they must be able and willing to have this treatment discontinued for the biopsy. Discontinuation procedures will be those of the treating site

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
2	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
3	Hawaii Cancer Care - Savio	'Aiea	Hawaii	United States	96701
4	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
5	Queen's Cancer Center - Pearlridge	'Aiea	Hawaii	United States	96701
6	The Cancer Center of Hawaii-Pali Momi	'Aiea	Hawaii	United States	96701
7	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii	United States	96813
8	Island Urology	Honolulu	Hawaii	United States	96813
9	Queen's Cancer Cenrer - POB I	Honolulu	Hawaii	United States	96813
10	Queen's Medical Center	Honolulu	Hawaii	United States	96813
11	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
12	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
13	Hawaii Cancer Care Inc-Liliha	Honolulu	Hawaii	United States	96817
14	Kuakini Medical Center	Honolulu	Hawaii	United States	96817
15	Queen's Cancer Center - Kuakini	Honolulu	Hawaii	United States	96817
16	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
17	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
18	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii	United States	96766
19	Illinois CancerCare-Bloomington	Bloomington	Illinois	United States	61704
20	Illinois CancerCare-Canton	Canton	Illinois	United States	61520
21	Memorial Hospital of Carbondale	Carbondale	Illinois	United States	62902
22	SIH Cancer Institute	Carterville	Illinois	United States	62918
23	Illinois CancerCare-Carthage	Carthage	Illinois	United States	62321
24	Centralia Oncology Clinic	Centralia	Illinois	United States	62801
25	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois	United States	62526
26	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
27	Illinois CancerCare-Dixon	Dixon	Illinois	United States	61021
28	Crossroads Cancer Center	Effingham	Illinois	United States	62401
29	Illinois CancerCare-Eureka	Eureka	Illinois	United States	61530
30	Illinois CancerCare-Galesburg	Galesburg	Illinois	United States	61401
31	Western Illinois Cancer Treatment Center	Galesburg	Illinois	United States	61401
32	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois	United States	61443
33	Illinois CancerCare-Macomb	Macomb	Illinois	United States	61455
34	Cancer Care Center of O'Fallon	O'Fallon	Illinois	United States	62269
35	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
36	Illinois CancerCare-Pekin	Pekin	Illinois	United States	61554
37	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
38	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
39	Illinois CancerCare-Peru	Peru	Illinois	United States	61354
40	Valley Radiation Oncology	Peru	Illinois	United States	61354
41	Illinois CancerCare-Princeton	Princeton	Illinois	United States	61356
42	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
43	Springfield Clinic	Springfield	Illinois	United States	62702
44	Memorial Medical Center	Springfield	Illinois	United States	62781
45	Southwest Illinois Health Services LLP	Swansea	Illinois	United States	62226
46	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa	United States	52402
47	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
48	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
49	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
50	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
51	Methodist West Hospital	West Des Moines	Iowa	United States	50266-7700
52	East Jefferson General Hospital	Metairie	Louisiana	United States	70006
53	Louisiana State University Health Science Center	New Orleans	Louisiana	United States	70112
54	University Medical Center New Orleans	New Orleans	Louisiana	United States	70112
55	Mercy Medical Center	Springfield	Massachusetts	United States	01104
56	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
57	Saint Joseph Mercy Brighton	Brighton	Michigan	United States	48114
58	Trinity Health IHA Medical Group Hematology Oncology - Brighton	Brighton	Michigan	United States	48114
59	Saint Joseph Mercy Canton	Canton	Michigan	United States	48188
60	Trinity Health IHA Medical Group Hematology Oncology - Canton	Canton	Michigan	United States	48188
61	Caro Cancer Center	Caro	Michigan	United States	48723
62	Saint Joseph Mercy Chelsea	Chelsea	Michigan	United States	48118
63	Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital	Chelsea	Michigan	United States	48118
64	Hematology Oncology Consultants-Clarkston	Clarkston	Michigan	United States	48346
65	Newland Medical Associates-Clarkston	Clarkston	Michigan	United States	48346
66	Ascension Saint John Hospital	Detroit	Michigan	United States	48236
67	Great Lakes Cancer Management Specialists-Doctors Park	East China Township	Michigan	United States	48054
68	Genesee Cancer and Blood Disease Treatment Center	Flint	Michigan	United States	48503
69	Genesee Hematology Oncology PC	Flint	Michigan	United States	48503
70	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
71	Hurley Medical Center	Flint	Michigan	United States	48503
72	Academic Hematology Oncology Specialists	Grosse Pointe Woods	Michigan	United States	48236
73	Great Lakes Cancer Management Specialists-Van Elslander Cancer Center	Grosse Pointe Woods	Michigan	United States	48236
74	Michigan Breast Specialists-Grosse Pointe Woods	Grosse Pointe Woods	Michigan	United States	48236
75	Sparrow Hospital	Lansing	Michigan	United States	48912
76	Hope Cancer Clinic	Livonia	Michigan	United States	48154
77	Trinity Health Saint Mary Mercy Livonia Hospital	Livonia	Michigan	United States	48154
78	Great Lakes Cancer Management Specialists-Macomb Medical Campus	Macomb	Michigan	United States	48044
79	Michigan Breast Specialists-Macomb Township	Macomb	Michigan	United States	48044
80	Saint Mary's Oncology/Hematology Associates of Marlette	Marlette	Michigan	United States	48453
81	21st Century Oncology-Pontiac	Pontiac	Michigan	United States	48341
82	Hope Cancer Center	Pontiac	Michigan	United States	48341
83	Newland Medical Associates-Pontiac	Pontiac	Michigan	United States	48341
84	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
85	Great Lakes Cancer Management Specialists-Rochester Hills	Rochester Hills	Michigan	United States	48309
86	Ascension Saint Mary's Hospital	Saginaw	Michigan	United States	48601
87	Oncology Hematology Associates of Saginaw Valley PC	Saginaw	Michigan	United States	48604
88	Bhadresh Nayak MD PC-Sterling Heights	Sterling Heights	Michigan	United States	48312
89	Ascension Saint Joseph Hospital	Tawas City	Michigan	United States	48764
90	Advanced Breast Care Center PLLC	Warren	Michigan	United States	48088
91	Great Lakes Cancer Management Specialists-Macomb Professional Building	Warren	Michigan	United States	48093
92	Macomb Hematology Oncology PC	Warren	Michigan	United States	48093
93	Michigan Breast Specialists-Warren	Warren	Michigan	United States	48093
94	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
95	Saint Mary's Oncology/Hematology Associates of West Branch	West Branch	Michigan	United States	48661
96	Huron Gastroenterology PC	Ypsilanti	Michigan	United States	48106
97	Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus	Ypsilanti	Michigan	United States	48197
98	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
99	Minnesota Oncology - Burnsville	Burnsville	Minnesota	United States	55337
100	Cambridge Medical Center	Cambridge	Minnesota	United States	55008
101	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
102	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
103	Unity Hospital	Fridley	Minnesota	United States	55432
104	Fairview Clinics and Surgery Center Maple Grove	Maple Grove	Minnesota	United States	55369
105	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
106	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
107	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
108	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
109	Health Partners Inc	Minneapolis	Minnesota	United States	55454
110	Monticello Cancer Center	Monticello	Minnesota	United States	55362
111	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
112	Fairview Northland Medical Center	Princeton	Minnesota	United States	55371
113	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
114	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
115	Regions Hospital	Saint Paul	Minnesota	United States	55101
116	United Hospital	Saint Paul	Minnesota	United States	55102
117	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
118	Lakeview Hospital	Stillwater	Minnesota	United States	55082
119	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
120	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
121	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
122	Fairview Lakes Medical Center	Wyoming	Minnesota	United States	55092
123	Parkland Health Center-Bonne Terre	Bonne Terre	Missouri	United States	63628
124	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
125	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
126	Parkland Health Center - Farmington	Farmington	Missouri	United States	63640
127	Capital Region Southwest Campus	Jefferson City	Missouri	United States	65109
128	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
129	Sainte Genevieve County Memorial Hospital	Sainte Genevieve	Missouri	United States	63670
130	Missouri Baptist Sullivan Hospital	Sullivan	Missouri	United States	63080
131	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri	United States	63127
132	Montefiore Medical Center-Einstein Campus	Bronx	New York	United States	10461
133	Montefiore Medical Center-Weiler Hospital	Bronx	New York	United States	10461
134	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
135	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
136	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	United States	18103
137	Lehigh Valley Hospital - Muhlenberg	Bethlehem	Pennsylvania	United States	18017
138	Pocono Medical Center	East Stroudsburg	Pennsylvania	United States	18301
139	Lehigh Valley Hospital-Hazleton	Hazleton	Pennsylvania	United States	18201
140	Aurora Cancer Care-Grafton	Grafton	Wisconsin	United States	53024
141	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
142	Cancer Center of Western Wisconsin	New Richmond	Wisconsin	United States	54017
143	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227
144	Doctors Cancer Center	Manati		Puerto Rico	00674