Esophageal Cancer Clinical Trial
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.
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.
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.
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.
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
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)
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
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There are 97 Locations for this study
Des Moines Iowa, 50309, United States
Shreveport Louisiana, 71103, United States
Lewiston Maine, 04240, United States
Grand Island Nebraska, 68803, United States
Newton New Jersey, 07860, United States
Charlotte North Carolina, 28204, United States
Lynchburg Virginia, 24501, United States
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