RecruitingNCT04314401
National Cancer Institute "Cancer Moonshot Biobank"
Cancer Moonshot Biobank Research Protocol
Sponsor
National Cancer Institute (NCI)
Enrollment
1,600 participants
Start Date
Nov 11, 2020
Study Type
OBSERVATIONAL
Conditions
Ovarian CarcinomaEsophageal CarcinomaGastric CarcinomaMalignant Solid NeoplasmPrimary Peritoneal CarcinomaMelanomaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Stage III Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Triple-Negative Breast CarcinomaMetastatic Prostate CarcinomaStage III Ovarian Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Hormone Receptor-Positive Breast CarcinomaStage IV Colorectal Cancer AJCC v8Acute Myeloid LeukemiaInvasive Breast CarcinomaFallopian Tube CarcinomaMultiple MyelomaLung Non-Small Cell CarcinomaClinical Stage IV Esophageal Adenocarcinoma AJCC v8Lung Small Cell CarcinomaOvarian High Grade Serous AdenocarcinomaStage III Fallopian Tube Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8
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.
Eligibility
Min Age: 13 Years
Inclusion Criteria45
- 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
- Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above
- 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 optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
- Contains at least 10% tumor content. 70% tumor content is optimal, 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, and while patient is on treatment
- Age 13 or older
- Any sex
- 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)
- Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
- African American with triple negative (ER-PR-HER2-)
Exclusion Criteria11
- Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
- For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed
- 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)
- 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
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
PROCEDUREComputed Tomography
Undergo CT
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
OTHERMedical Chart Review
Medical charts are reviewed and data is collected
PROCEDUREParacentesis
Undergo paracentesis
PROCEDUREPositron Emission Tomography
Undergo PET/CT
Locations(152)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04314401
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