National Cancer Institute Cancer Moonshot Biobank

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. 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 and other National Clinical Trials Network (NCTN) sites. SECONDARY OBJECTIVES: I. 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. II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from up to 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators. III. 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. IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities. V. 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. VI. 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, post 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 5 years.

Official Title
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Cancer Moonshot Biobank Research Protocol

Conditions
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Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Lung Non-Small Cell Carcinoma, Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Metastatic Prostate Carcinoma, Multiple Myeloma, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Medical Chart Review


Participation Criteria
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Eligibility Criteria
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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 prostate cancer Gastric cancer, not otherwise specified (NOS): stage IV Esophageal cancer, NOS: stage IV Adenocarcinoma of gastroesophageal junction: stage IV High grade serous ovarian cancer: stage III/IV Invasive breast carcinoma: stage III/IV Melanoma: stage III/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 (BM) 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, BM 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 Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection Blood collection for clinical scenario d must take place within 4 weeks of 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 Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use Factor X inhibitors are permitted Use of anti-platelet drugs are permitted Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP) NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) 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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-correlative (biospecimen collection, chart review)<br>Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, post 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 5 years. | Procedure: Biospecimen Collection<br>* Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples<br>* Other names: Specimen Collection;Other: Medical Chart Review<br>* Medical charts are reviewed and data is collected<br>* Other names: Chart Review;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procure, store and distribute longitudinal biospecimens and associated clinical data | 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. | Up to 10 years | 
| Percentage of enrolled patients by cancer type and treatment regimen overall | 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. | Until completion of biospecimen collection, up to 3 years | 
| Percentage of minority and underserved study participants accrued | Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. | Until completion of biospecimen collection, up to 3 years | 

Secondary Outcome Measures

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