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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04314401
Other study ID # NCI-2020-00750
Secondary ID NCI-2020-0075010
Status Recruiting
Phase
First received
Last updated
Start date November 11, 2020
Est. completion date September 16, 2025

Study information

Verified date February 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date September 16, 2025
Est. primary completion date September 16, 2025
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Acute Myeloid Leukemia
  • Adenocarcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Small Cell
  • 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
  • Esophageal Squamous Cell Carcinoma
  • Lung Neoplasms
  • Lung Non-Small Cell Carcinoma
  • Lung Small Cell Carcinoma
  • Malignant Solid Neoplasm
  • Melanoma
  • Metastatic Prostate Carcinoma
  • Multiple Myeloma
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Skin Neoplasms
  • Small Cell Lung Carcinoma
  • 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
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Intervention

Procedure:
Biospecimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
Other:
Medical Chart Review
Medical charts are reviewed and data is collected

Locations

Country Name City State
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States McFarland Clinic - Ames Ames Iowa
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States PCR Oncology Arroyo Grande California
United States Northside Hospital Atlanta Georgia
United States Harold Alfond Center for Cancer Care Augusta Maine
United States AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Our Lady of the Lake Physician Group Baton Rouge Louisiana
United States Waldo County General Hospital Belfast Maine
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Boca Raton Regional Hospital Boca Raton Florida
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Children's Hospital at Montefiore Bronx New York
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States MaineHealth Cancer Care - Brunswick Brunswick Maine
United States Mid Coast Hospital Brunswick Maine
United States Trinity Health Medical Center - Canton Canton Michigan
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Chelsea Hospital Chelsea Michigan
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Prisma Health Baptist Hospital Columbia South Carolina
United States Prisma Health Richland Hospital Columbia South Carolina
United States LincolnHealth - Miles Campus and Hospital Damariscotta Maine
United States Carle at The Riverfront Danville Illinois
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Blank Children's Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Bayhealth Hospital Kent Campus Dover Delaware
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Thomas Hospital Fairhope Alabama
United States Franklin Memorial Hospital Farmington Maine
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Kingman Regional Medical Center Kingman Arizona
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States Saint Mary's Regional Medical Center Lewiston Maine
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Centra Alan B Pearson Regional Cancer Center Lynchburg Virginia
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Bayhealth Hospital Sussex Campus Milford Delaware
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Mobile Infirmary Medical Center Mobile Alabama
United States Morristown Medical Center Morristown New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Saint Joseph Hospital Nashua New Hampshire
United States Children's Hospital New Orleans New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Newton Medical Center Newton New Jersey
United States Stephens Memorial Hospital Norway Maine
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States Chilton Medical Center Pompton New Jersey
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Maine Medical Partners Surgical Care Portland Maine
United States MMP Surgical Care Casco Bay Portland Maine
United States Valley Medical Center Renton Washington
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Penobscot Bay Medical Center Rockport Maine
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Maine Children's Cancer Program Scarborough Maine
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Maine Medical Partners Neurology Scarborough Maine
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Maine Medical Partners - South Portland South Portland Maine
United States Maine Medical Partners Urology South Portland Maine
United States Spartanburg Medical Center Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Overlook Hospital Summit New Jersey
United States Tampa General Hospital Tampa Florida
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States Illinois CancerCare - Washington Washington Illinois
United States Mercy Hospital Washington Washington Missouri
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Novant Health Forsyth Medical Center Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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 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
Secondary 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
Secondary 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
Secondary 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
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