Status:
RECRUITING
National Cancer Institute "Cancer Moonshot Biobank"
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Anatomic Stage III Breast Cancer AJCC v8
Eligibility:
All Genders
13+ years
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 sa...
Detailed 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 pro...
Eligibility Criteria
Inclusion
- 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)
- NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
- NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
- NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either
- Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
- African American with triple negative (ER-PR-HER2-)
- NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML)
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
November 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT04314401
Start Date
November 11 2020
End Date
April 30 2027
Last Update
January 9 2026
Active Locations (152)
Enter a location and click search to find clinical trials sorted by distance.
1
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, United States, 36526
2
Thomas Hospital
Fairhope, Alabama, United States, 36532
3
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
4
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, United States, 36571