RECRUITING

Collection and Storage of Tissue and Blood Samples From Patients With Cancer

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 study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.

Official Title

Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)

Quick Facts

Study Start:2015-05-19
Study Completion:2026-05-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02474160

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:2 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients older than 2 months of age who are being evaluated, treated, or enrolled in a clinical trial for cancer at participating sites
  2. * Patients with a histologically or cytologically confirmed diagnosis of cancer
  3. * Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator
  4. * Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician:
  5. * Radiographic imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], etc.)
  6. * Elevated tumor markers
  7. * Clinical symptoms
  8. * Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and/or known familial cancer history or syndrome
  9. * Complete blood count (CBC) w/differential indicative of a probable hematologic malignancy
  10. * If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred
  11. * Important: Additional medical, genetic and/or demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria
  12. * Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologic malignancy for which they have not yet received treatment
  13. * Patients with a solid tumor or hematologic malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by:
  14. * Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR
  15. * Documentation by the treating physician of clinical disease progression, OR
  16. * CBC w/differential and/or flow cytometry for hematologic malignancies
  17. * Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.)
  18. * Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle)
  19. * Specimens should not be collected from patients between doses within a single treatment cycle
  20. * Confirmation of viable residual malignancy and/or \< 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
  21. * Patients with ongoing partial response (PR) or stable disease (SD) are eligible
  22. * Confirmation of viable malignancy and/or \< 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
  23. * Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol
  24. * For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable/age appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines
  1. * Patients with cancer-like syndromes and/or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS)
  2. * Patients with invasive fungal infections
  3. * Patients with active and/or uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection
  4. * Actively febrile patients with uncertain etiology of febrile episode
  5. * All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection
  6. * Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and/or anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded
  7. * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
  8. * Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxis are permissible
  9. * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible
  10. * 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 HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated
  11. * Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity
  12. * Patients that are anti-HAV IgG reactive only are eligible
  13. * Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR)

Contacts and Locations

Principal Investigator

James H Doroshow
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
PCR Oncology
Arroyo Grande, California, 93420
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
Yale University
New Haven, Connecticut, 06520
United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Radiation Oncology of Northern Illinois
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Valley Radiation Oncology
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905
United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502
United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357
United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124
United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401
United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
United States
Associates In Womens Health
Wichita, Kansas, 67208
United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
United States
Wesley Medical Center
Wichita, Kansas, 67214
United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Bronson Battle Creek
Battle Creek, Michigan, 49017
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Ascension Borgess Hospital
Kalamazoo, Michigan, 49048
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
United States
Cox Cancer Center Branson
Branson, Missouri, 65616
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
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
Washington University School of Medicine
Saint Louis, Missouri, 63110
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
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106
United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109
United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113
United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, 89121
United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128
United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128
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
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
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
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001
United States
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, 98110
United States
Virginia Mason Federal Way Medical Center
Federal Way, Washington, 98002
United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335
United States
Virginia Mason Lynnwood Medical Center
Lynnwood, Washington, 98036
United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: National Cancer Institute LAO

  • James H Doroshow, 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 Date2015-05-19
Study Completion Date2026-05-04

Study Record Updates

Study Start Date2015-05-19
Study Completion Date2026-05-04

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Malignant Solid Neoplasm