RECRUITING

National Cancer Institute "Cancer Moonshot Biobank"

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Conditions

Acute Myeloid LeukemiaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Lung Non-Small Cell CarcinomaLung Small Cell CarcinomaMalignant Solid NeoplasmMetastatic Prostate CarcinomaMultiple MyelomaStage III Lung Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cancer Moonshot Biobank Research Protocol

Quick Facts

Study Start:2020-11-11
Study Completion:2025-09-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04314401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is consistent with OR has been diagnosed with one of the following:
  2. * Colorectal cancer: Stage IV
  3. * Non-small cell or small cell lung cancer: stage III/IV
  4. * Prostate cancer: metastatic prostate cancer
  5. * Gastric cancer, not otherwise specified (NOS): stage IV
  6. * Esophageal cancer, NOS: stage IV
  7. * Adenocarcinoma of gastroesophageal junction: stage IV
  8. * High grade serous ovarian cancer: stage III/IV
  9. * Invasive breast carcinoma: stage III/IV
  10. * Melanoma: stage III/IV
  11. * Acute myeloid leukemia
  12. * Multiple myeloma
  13. * For the purposes of this study, re-staging is allowed
  14. * Patient should fit in one of the following four clinical scenarios (a-d)
  15. * Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
  16. * Scheduled to begin treatment with a new regimen of standard of care therapy OR
  17. * Currently progressing on a regimen of standard of care therapy OR
  18. * Currently being treated with a regimen standard of care therapy, without evidence of progression
  19. * Requirements for fresh tissue biospecimen collections at enrollment:
  20. * For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment
  21. * For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
  22. * For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
  23. * For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
  24. * 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
  25. * 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
  26. * Requirements for archival tissue:
  27. * For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
  28. * For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
  29. * Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that:
  30. * Contains the cancer type for which the participant is enrolled, and
  31. * Was collected no more than 5 years prior to initiation of therapy, and
  32. * 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
  33. * 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
  34. * Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment
  35. * Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
  36. * Blood collection for clinical scenario d must take place within 4 weeks of enrollment
  37. * Age 13 or older
  38. * Any sex and any gender
  39. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
  40. * 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)
  1. * Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
  2. * Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
  3. * 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
  4. * Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use
  5. * Factor X inhibitors are permitted
  6. * Use of anti-platelet drugs are permitted
  7. * Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)
  8. * NCI PDMR

Contacts and Locations

Principal Investigator

Helen M Moore
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

Thomas Hospital
Fairhope, Alabama, 36532
United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
United States
Kingman Regional Medical Center
Kingman, Arizona, 86401
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
PCR Oncology
Arroyo Grande, California, 93420
United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
United States
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, 80401
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901
United States
Bayhealth Hospital Sussex Campus
Milford, Delaware, 19963
United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
United States
Broward Health North
Deerfield Beach, Florida, 33064
United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
McFarland Clinic - Ames
Ames, Iowa, 50010
United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
United States
Blank Children's Hospital
Des Moines, Iowa, 50309
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
United States
Waldo County General Hospital
Belfast, Maine, 04915
United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine, 04005
United States
MaineHealth Cancer Care - Brunswick
Brunswick, Maine, 04011
United States
Mid Coast Hospital
Brunswick, Maine, 04011
United States
LincolnHealth - Miles Campus and Hospital
Damariscotta, Maine, 04543
United States
Franklin Memorial Hospital
Farmington, Maine, 04938
United States
Saint Mary's Regional Medical Center
Lewiston, Maine, 04240
United States
Stephens Memorial Hospital
Norway, Maine, 04268
United States
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
United States
Maine Medical Partners Surgical Care
Portland, Maine, 04102
United States
MMP Surgical Care Casco Bay
Portland, Maine, 04102
United States
Penobscot Bay Medical Center
Rockport, Maine, 04856
United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine, 04073
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074
United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
United States
Maine Medical Partners Neurology
Scarborough, Maine, 04074
United States
Maine Medical Partners - South Portland
South Portland, Maine, 04106
United States
Maine Medical Partners Urology
South Portland, Maine, 04106
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
United States
Freeman Health System
Joplin, Missouri, 64804
United States
Mercy Hospital Joplin
Joplin, Missouri, 64804
United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
United States
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, 63109
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Mercy Hospital Washington
Washington, Missouri, 63090
United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
United States
Saint Joseph Hospital
Nashua, New Hampshire, 03060
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Newton Medical Center
Newton, New Jersey, 07860
United States
Chilton Medical Center
Pompton, New Jersey, 07444
United States
Overlook Hospital
Summit, New Jersey, 07902
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
United States
Children's Hospital at Montefiore
Bronx, New York, 10467
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
United States
East Carolina University
Greenville, North Carolina, 27834
United States
ECU Health Medical Center
Greenville, North Carolina, 27834
United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
United States
ECU Health Oncology Kinston
Kinston, North Carolina, 28501
United States
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
United States
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
Washington, North Carolina, 27889
United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
Roger Williams Medical Center
Providence, Rhode Island, 02908
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
Prisma Health Baptist Hospital
Columbia, South Carolina, 29220
United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379
United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Valley Medical Center
Renton, Washington, 98055
United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902
United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Helen M Moore, PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-11
Study Completion Date2025-09-16

Study Record Updates

Study Start Date2020-11-11
Study Completion Date2025-09-16

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Lung Non-Small Cell Carcinoma
  • Lung Small Cell Carcinoma
  • Malignant Solid Neoplasm
  • Metastatic Prostate Carcinoma
  • Multiple Myeloma
  • Stage III Lung Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8