National Cancer Institute "Cancer Moonshot Biobank"

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT04314401

Collaborator

(none)

1,000

Enrollment

100

Locations

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Castration-Resistant Prostate Carcinoma Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma 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 Lung Non-Small Cell Carcinoma Lung Small Cell Carcinoma Malignant Solid Neoplasm Pathologic Stage III Cutaneous Melanoma AJCC v8 Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8 Pathologic Stage IV Cutaneous Melanoma 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 Plasma Cell Myeloma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8	Procedure: Biospecimen Collection Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVE:

To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites.

SECONDARY OBJECTIVES:

To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms.
To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators.
To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research.
To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities.
To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGAP), including clinical, radiology and pathology data with an emphasis on treatment response and outcome data.
To provide residual biospecimens and associated data from the project to the cancer research community.

OUTLINE:

Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, and at disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected, if available. Patient medical records are reviewed, and data is collected for at least 10 years.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cancer Moonshot Biobank Research Protocol

Actual Study Start Date :

Sep 17, 2020

Anticipated Primary Completion Date :

Sep 16, 2025

Anticipated Study Completion Date :

Sep 16, 2025

Arms and Interventions

Arm	Intervention/Treatment
Ancillary-correlative (biospecimen collection, chart review) Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, and at disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected, if available. Patient medical records are reviewed, and data is collected for at least 10 years.	Procedure: Biospecimen Collection Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Other: Medical Chart Review Medical charts are reviewed and data is collected Other Names: Chart Review

Arm

Intervention/Treatment

Ancillary-correlative (biospecimen collection, chart review)

Procedure: Biospecimen Collection

Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples

Other Names:

Biological Sample Collection

Biospecimen Collected

Specimen Collection

Other: Medical Chart Review

Medical charts are reviewed and data is collected

Other Names:

Chart Review

Outcome Measures

Primary Outcome Measures

Procure, store and distribute longitudinal biospecimens and associated clinical data [Up to 10 years]
Will procure, store and distribute longitudinal biospecimens and associated clinical data for current and future cancer research in order to elucidate molecular mechanisms of sensitivity and intrinsic or acquired resistance to standard of care systemic therapies, including immunotherapy. Cases will be grouped according to patient demographics, cancer type and treatment regimen. Statistical analysis will be descriptive and will be analyzed for each Biospecimen Source Site (BSS) as well as study aggregate.
Percentage of enrolled patients by cancer type and treatment regimen overall [Until completion of biospecimen collection, up to 3 years]
Will assess the percentage of enrolled patients by cancer type and treatment regimen overall and those who contribute samples to the Drug Resistance and Sensitivity Network and other approved investigators. Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Percentage of minority and underserved study participants accrued [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.

Secondary Outcome Measures

Pan-cancer gene panel tumor next generation sequencing test [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Cancer Research Data Commons, The Cancer Imaging Archive and database of Genotypes and Phenotypes data contribution [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Percentage of minority and underserved study participants accrued [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.
Percentage of enrolled patients for whom molecular profiling is attempted [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Percentage of enrolled patients for whom molecular profiling results are generated [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.
Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository [Until completion of biospecimen collection, up to 3 years]
Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Is consistent with OR has been diagnosed with one of the following:
Colorectal cancer: Stage IV
Non-small cell or small cell lung cancer: stage III/IV
Prostate cancer: metastatic castration-resistant prostate cancer
Gastroesophageal cancer: stage IV
Melanoma: clinical stage IV with pathologic stage III OR clinical stage IV
Acute myeloid leukemia
Multiple myeloma
For the purposes of this study, re-staging is allowed
Patient should fit in one of the following four clinical scenarios (a-d)
Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
Scheduled to begin treatment with a new regimen of standard of care therapy OR
Currently progressing on a regimen of standard of care therapy OR
Currently being treated with a regimen standard of care therapy, without evidence of progression
Requirements for fresh tissue biospecimen collections at enrollment:
For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow aspirate must be submitted at enrollment
For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling
Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state
Requirements for archival tissue:
For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
Pre-existing archival material (formalin-fixed, paraffin-embedded [FFPE] block, bone marrow aspirate, or unstained slides) that:
Contains the cancer type for which the participant is enrolled, and
Was collected no more than 5 years prior to initiation of therapy, and
Contains at least a surface area of 5 mm^{2 and optimum surface area of 25
mm}2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy
Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment
Age 13 or older
Any sex and any gender
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)

Exclusion Criteria:

Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
On chronic anticoagulation treatment that cannot be discontinued during the time interval necessary to undergo a biopsy
NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient or microsatellite instability-high
NCI PDMR EXCLUSION CRITERIA: Patients with complete response
NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections
NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection
Actively febrile patients with uncertain etiology of febrile episode
All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HBV/HCV without documented resolution

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kingman Regional Medical Center	Kingman	Arizona	United States	86401
2	Mercy Hospital Fort Smith	Fort Smith	Arkansas	United States	72903
3	PCR Oncology	Arroyo Grande	California	United States	93420
4	Northside Hospital	Atlanta	Georgia	United States	30342
5	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
6	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612
7	Carle on Vermilion	Danville	Illinois	United States	61832
8	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois	United States	62526
9	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
10	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
11	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
12	Carle Cancer Center	Urbana	Illinois	United States	61801
13	McFarland Clinic PC - Ames	Ames	Iowa	United States	50010
14	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa	United States	52402
15	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
16	Blank Children's Hospital	Des Moines	Iowa	United States	50309
17	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
18	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
19	Our Lady of the Lake Physicians Group - Medical Oncology	Baton Rouge	Louisiana	United States	70809
20	University Medical Center New Orleans	New Orleans	Louisiana	United States	70112
21	Children's Hospital New Orleans	New Orleans	Louisiana	United States	70118
22	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana	United States	71103
23	Harold Alfond Center for Cancer Care	Augusta	Maine	United States	04330
24	Waldo County General Hospital	Belfast	Maine	United States	04915
25	MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford	Biddeford	Maine	United States	04005
26	Franklin Memorial Hospital	Farmington	Maine	United States	04938
27	Stephens Memorial Hospital	Norway	Maine	United States	04268
28	Maine Medical Center-Bramhall Campus	Portland	Maine	United States	04102
29	Maine Medical Partners Surgical Care	Portland	Maine	United States	04102
30	MMP Surgical Care Casco Bay	Portland	Maine	United States	04102
31	Penobscot Bay Medical Center	Rockport	Maine	United States	04856
32	MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford	Sanford	Maine	United States	04073
33	Maine Children's Cancer Program	Scarborough	Maine	United States	04074
34	Maine Medical Partners Neurology	Scarborough	Maine	United States	04074
35	Maine Medical Partners - South Portland	South Portland	Maine	United States	04106
36	Maine Medical Partners Urology	South Portland	Maine	United States	04106
37	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
38	Saint Joseph Mercy Brighton	Brighton	Michigan	United States	48114
39	Saint Joseph Mercy Canton	Canton	Michigan	United States	48188
40	Saint Joseph Mercy Chelsea	Chelsea	Michigan	United States	48118
41	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
42	Saint Louis Cancer and Breast Institute-Ballwin	Ballwin	Missouri	United States	63011
43	Freeman Health System	Joplin	Missouri	United States	64804
44	Mercy Hospital Joplin	Joplin	Missouri	United States	64804
45	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
46	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
47	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
48	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri	United States	63109
49	Mercy Hospital South	Saint Louis	Missouri	United States	63128
50	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
51	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
52	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
53	CoxHealth South Hospital	Springfield	Missouri	United States	65807
54	Mercy Hospital Washington	Washington	Missouri	United States	63090
55	CHI Health Saint Francis	Grand Island	Nebraska	United States	68803
56	Carson Tahoe Regional Medical Center	Carson City	Nevada	United States	89703
57	OptumCare Cancer Care at Seven Hills	Henderson	Nevada	United States	89052
58	OptumCare Cancer Care at Charleston	Las Vegas	Nevada	United States	89102
59	Hope Cancer Care of Nevada	Las Vegas	Nevada	United States	89103
60	Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada	United States	89135
61	Comprehensive Cancer Centers of Nevada - Town Center	Las Vegas	Nevada	United States	89144
62	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89148
63	OptumCare Cancer Care at Fort Apache	Las Vegas	Nevada	United States	89148
64	Comprehensive Cancer Centers of Nevada - Central Valley	Las Vegas	Nevada	United States	89169
65	Morristown Medical Center	Morristown	New Jersey	United States	07960
66	Newton Medical Center	Newton	New Jersey	United States	07860
67	Chilton Medical Center	Pompton	New Jersey	United States	07444
68	Overlook Hospital	Summit	New Jersey	United States	07902
69	Montefiore Medical Center-Einstein Campus	Bronx	New York	United States	10461
70	Montefiore Medical Center-Weiler Hospital	Bronx	New York	United States	10461
71	Children's Hospital at Montefiore	Bronx	New York	United States	10467
72	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
73	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
74	Novant Health Presbyterian Medical Center	Charlotte	North Carolina	United States	28204
75	FirstHealth of the Carolinas-Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
76	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
77	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma	United States	73120
78	Prisma Health Richland Hospital	Columbia	South Carolina	United States	29203
79	Prisma Health Baptist Hospital	Columbia	South Carolina	United States	29220
80	Gibbs Cancer Center-Gaffney	Gaffney	South Carolina	United States	29341
81	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
82	Gibbs Cancer Center-Pelham	Greer	South Carolina	United States	29651
83	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
84	MGC Hematology Oncology-Union	Union	South Carolina	United States	29379
85	Centra Lynchburg Hematology-Oncology Clinic Inc	Lynchburg	Virginia	United States	24501
86	VCU Massey Cancer Center at Stony Point	Richmond	Virginia	United States	23235
87	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
88	Valley Medical Center	Renton	Washington	United States	98055
89	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
90	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin	United States	54701
91	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
92	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
93	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
94	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin	United States	54868
95	Marshfield Medical Center-River Region at Stevens Point	Stevens Point	Wisconsin	United States	54482
96	Marshfield Medical Center - Weston	Weston	Wisconsin	United States	54476
97	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
98	San Juan Community Oncology Group	San Juan		Puerto Rico	00917
99	Centro Comprensivo de Cancer de UPR	San Juan		Puerto Rico	00927
100	San Juan City Hospital	San Juan		Puerto Rico	00936