NCI ID NCI-2020-00750
NCT ID NCT04314401
CTEP ID 10323
Primary Purpose OTHER
Anatomic Sites Multiple
Minimum Age 13 Years
Maximum Age 999 Years
Gender BOTH
Lead Org National Cancer Institute
Principal Investigator Helen M. Moore
NCI Site View on ClinicalTrials.gov

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.

Eligibility

Inclusion Criterea

  • 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 castration-resistant prostate cancer * Gastroesophageal cancer: stage IV * Melanoma: clinical stage IV with pathologic stage III OR clinical stage 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 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, bone marrow 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
  • 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 Criterea

  • 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
  • On chronic anticoagulation treatment that cannot be discontinued during the time interval necessary to undergo a biopsy
  • NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient or microsatellite instability-high
  • 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

Participating Clinics

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital


808 North 39th Avenue
Yakima, WA 98902
Map

509-574-3535
Memorial-ClinicalTrials@yvmh.org

OptumCare Cancer Care at Charleston


2300 West Charleston Boulevard
Las Vegas, NV 89102
Map

702-384-0013

Kingman Regional Medical Center


3269 Stockton Hill Road
Kingman, AZ 86401
Map

702-384-0013
research@sncrf.org

PCR Oncology


584 Camino Mercado
Arroyo Grande, CA 93420
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley


3730 South Eastern Avenue
Las Vegas, NV 89169
Map

702-384-0013
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation


One Breakthrough Way
Las Vegas, NV 89135
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada


9280 West Sunset Road
Suite 100 Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Carson Tahoe Regional Medical Center


1535 Medical Parkway
Pharmacy Suite C Carson City, NV 89703
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center


653 North Town Center Drive
Suite 402 Las Vegas, NV 89144
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills


3175 Saint Rose Parkway
Suite 200 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada


6827 West Tropicana Avenue
Suite 110 Las Vegas, NV 89103
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache


6190 South Fort Apache Road
Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Valley Medical Center


400 South 43rd Street
Renton, WA 98055
Map

425-228-3440
research@valleymed.org