Actively Recruiting

Age: 2Months +
All Genders
NCT00900198

Collection of Tissue Samples for Cancer Research

Led by National Cancer Institute (NCI) · Updated on 2026-04-14

5000

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: -Patients who are being evaluated and/or treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives: * To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. * To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Eligibility: -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center participating sites. Design: * This is a multicenter tissue procurement protocol with NCI as the coordinating center. * For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol. * For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits. * Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture. * This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models. * Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

CONDITIONS

Official Title

Collection of Tissue Samples for Cancer Research

Who Can Participate

Age: 2Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years and older being evaluated or treated for cancer at NIH Clinical Center or participating sites
  • Patients with newly diagnosed cancer or recurrent/progressing malignancy confirmed by tests or physician assessment
  • Patients currently undergoing treatment with disease response not yet assessed
  • Patients with ongoing partial response or stable disease (solid tumors require pathology confirmation; hematologic malignancies require flow cytometry confirmation)
  • Ability to understand and sign informed consent for tissue or fluid research use
  • At NIH only, specimens may be collected from adults with confirmed familial cancer syndromes
  • Patients 18 years and older with hematologic malignancies meeting adult criteria
  • Pediatric patients younger than 18 years and older than 2 months with confirmed cancer diagnosis undergoing clinically necessary procedures
  • Pediatric patients able and willing to assent and have parental permission
  • At NIH only, tissue collections may include some benign tumors known for malignant transformation
Not Eligible

You will not qualify if you...

  • Patients with cancer-like syndromes or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance
  • Patients with invasive fungal infections
  • Patients with active, uncontrolled infections or recovering from infection (antibiotics must be completed at least 7 days prior, no fever recurrence for 7 days; prophylactic antibiotics allowed)
  • Patients with HIV, active or chronic hepatitis B or C, or history of hepatitis B or C
  • Patients with Hepatitis A indicated by anti-HAV IgM reactivity
  • Blood only collections are excluded for patients with partial or stable disease response or between doses within a treatment cycle
  • Patients with benign tumors or ongoing complete disease response
  • Pediatric exclusion criteria mirror adult criteria, including infection status and benign tumor exclusions

AI-Screening

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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

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Research Team

N

Nancy A Moore, R.N.

CONTACT

J

James H Doroshow, M.D.

CONTACT

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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