Actively Recruiting
Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)
Led by National Cancer Institute (NCI) · Updated on 2026-06-01
5000
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting tissue and biological fluid samples from adult and pediatric patients being evaluated or treated for cancer at the NIH Clinical Center and participating sites. The study aims to support research by obtaining specimens from procedures required by a patient's primary treatment or for research purposes, including non-surgical biopsies. Specimens will help study cancer and develop preclinical models, with careful consent processes for invasive procedures. The study collects various types of samples such as blood, urine, tumor tissue, normal tissue, pleural fluid, cerebrospinal fluid, saliva, circulating tumor cells, hair follicles, and bone marrow. For adults, samples come from treatments or research protocols they are enrolled in, or from biopsies done solely for research. For pediatric patients, samples come only from clinically necessary procedures or scheduled bloodwork, with limits on volume collected. Separate consent forms are used for adults and pediatric patients to donate samples for ongoing research or model development. Participants stay in the study for the length of their consent or until planned procedures are completed. Samples are stored with unique identifiers and used only for approved research studies. The research team monitors sample collection on the day it occurs. Patients and guardians are informed about risks and side effects of invasive procedures before consenting. Minimally invasive collections like blood draws do not require separate consent.
CONDITIONS
Brief Title
Collection of Tissue Samples for Cancer Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older being evaluated or treated for cancer at the NIH Clinical Center or participating sites
- Patients with newly diagnosed or recurrent/progressing malignancy, or undergoing treatment with unassessed response
- Patients with ongoing partial response or stable disease with confirmation of viable malignancy as needed
- Ability to understand and sign informed consent for tissue or fluid donation
- Pediatric patients older than 2 months and younger than 18 years with confirmed cancer diagnosis undergoing clinically necessary procedures
- Pediatric patients able and willing to assent with parental permission
- At NIH, patients with familial cancer syndromes or certain hematologic malignancies may be eligible under PI discretion
You will not qualify if you...
- Patients with cancer-like syndromes or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, or MGUS
- Patients with invasive fungal infections
- Patients with active or uncontrolled infections or recovering from infections without at least 7 days symptom-free after antibiotics
- Patients with HIV, active or chronic hepatitis B or C, or known history of such infections
- Patients with Hepatitis A indicated by anti-HAV IgM reactivity
- Blood collection not performed on patients with ongoing partial response or stable disease due to poor model generation
- Specimen collection excluded from patients with benign tumors or complete disease response
- Pediatric exclusions mirror adult infections and benign tumor criteria
- Blood collection restrictions similar for pediatric patients with partial or stable disease response only between treatment cycles
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of consent or completion of planned procedures
Participants provide tissue and biological fluid samples obtained from clinically required procedures or minimally invasive procedures performed solely for research purposes.
Visits as needed depending on clinical procedures and research sampling
Trial Site Locations
Total: 17 locations
1
UC Davis
Sacramento, California, United States, 95616
Completed
2
University of Colorado, Denver
Aurora, Colorado, United States, 80220
Completed
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Indiana University - Purdue
Indianapolis, Indiana, United States, 46202-5262
Actively Recruiting
5
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
7
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
8
University of Michigan Ann Arbor
Ann Arbor, Michigan, United States, 48109-0624
Completed
9
Washington University - St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Roswell Park Cancer Institute
Buffalo, New York, United States
Actively Recruiting
11
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
12
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2582
Actively Recruiting
13
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Completed
14
University of Utah
Salt Lake City, Utah, United States, 84112
Completed
15
University of Virginia, Charlottesville
Charlottesville, Virginia, United States, 22903
Completed
16
Fred Hutchinson
Seattle, Washington, United States, 28104
Actively Recruiting
17
Princess Margaret Hospital Cancer Centre
Toronto, Canada
Completed
Research Team
N
Nancy A Moore, R.N.
J
James H Doroshow, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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