NCI Community Oncology Research Program (NCORP) Tissue Procurement Protocol: An NCI Cancer MoonshotSM Study
National Cancer Institute "Cancer Moonshot Biobank"
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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Patient diagnosed with Stage IV colorectal cancer, Stage III/IV non-small cell or small cell lung cancer, metastatic castration-resistant prostate cancer, stage IV gastroesophageal cancer, stage III/IV melanoma, or treatment refractory multiple myeloma, is undergoing first or subsequent lines of standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines and has consented to provide longitudinal biospecimens
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 may be enrolled retrospectively (i.e. at time of progression) if archival material is submitted that contains the cancer type for which the participant is enrolled and that was collected up to 5 years prior to initiation of a therapy, assuming that no more than 1 line of intervening standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy. Patients with a PS of 2 may be enrolled only at the discretion of the treating physician and radiologist
- Age 13 or older, any sex and any gender may be enrolled, but participants under the age of majority will only contribute biospecimens from procedures that are scheduled due to medical necessity and not for the sole purpose of collecting samples for this study
- Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. The biopsy must not be associated with a significant risk of severe or major complications or death. In particular, endoscopic, open or laparoscopic surgical procedures are not to be performed to provide research biospecimens. However, research biospecimens may be provided if the patient needs to undergo such procedures for clinical reasons. Severe or major complications are considered to be those:
- Requiring therapy, minor hospitalization (more than overnight but < 48 hours [h]).
- Requiring major therapy; unplanned increase in level of care, prolonged hospitalization > 48 h.
- Resulting in permanent adverse sequelae
- Resulting in death
- The following tumors may be collected only when patients will be undergoing a procedure due to medical necessity during which the tissue may be collected and not for the sole purpose of the clinical study:
- Brain biopsies: ONLY if the patient has medical necessity for craniotomy for clinical care
- Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies: ONLY to be obtained incidentally to a clinically necessary procedure
- Study participants with lung cancer (LCA), colorectal cancer (CRC), prostate cancer (PCA), gastroesophageal cancer (GEC), melanoma (MEL), and multiple myeloma (MML) may contribute samples for Patient Derived Models (PDM) development if they meet specific Patient Derived Models Repository (PDMR) eligibility criteria
- To ensure that individuals who experience diminished decision making capacity during the course of their cancer treatment are eligible, consent may be provided by a legally authorized representative (LAR) in accordance with 45 Code of Federal Regulations (CFR) 46.102(i). This protocol is minimal risk
- NCI PDMR INCLUSION CRITERIA: Baseline and progression timepoints
- NCI PDMR INCLUSION CRITERIA: CRC must be mismatch repair deficient and/or microsatellite instability-high
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Patients who are currently or have previously enrolled in an oncology interventional clinical trial
- Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
- If the patient is on chronic anticoagulation treatment, they must be able and willing to have this treatment discontinued for the biopsy. Discontinuation procedures will be those of the treating site
- Patients with CRC, LCA, PCA, GEC and MEL who are being evaluated at NCORP sites that are currently participating in the NCORP Tissue Procurement Protocol #10231
- 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
To learn more, visit ClinicalTrials.Gov
Michael Humeniuk, MD
National Cancer Institute