Collection of Blood From Patients With Cancer

May 29, 2026 updated by: National Cancer Institute (NCI)

Biospecimen Acquisition From Human Subjects

This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.

Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

  • Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:
  • the underlying mechanisms of tumor-specific immune response and suppression in cancer patients
  • genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis
  • investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes
  • identification of mechanisms of drug-related adverse events and correlation with clinical parameters
  • the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents

Objectives:

  • Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
  • Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
  • Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.

Eligibility:

  • Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.
  • 18 years of age or older.

Design:

- Cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.

Study Type

Observational

Enrollment (Estimated)

1750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Primary clinical; healthy volunteers may include NIH employees

Description

  • INCLUSION CRITERIA:

Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.

Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.

Ability to understand and the willingness to sign a written informed consent document.

INCLUSION FOR APHERESIS:

Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.

Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)

Weight greater than 25 kg

HIV negative

Prothrombin Time - within normal limits

Partial Thromboplastin Time - within normal limits

Medically indicated central line in place or adequate peripheral venous access

EXCLUSION CRITERIA:

None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy Volunteers
Healthy volunteers 18 years of age and older
Participants
Participants with cancer 18 years of age and older

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Time Frame: ongoing
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
ongoing
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Time Frame: ongoing
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
ongoing
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Time Frame: ongoing
Analyze tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jennifer L Marte, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

July 16, 2002

Study Registration Dates

First Submitted

April 24, 2002

First Submitted That Met QC Criteria

April 23, 2002

First Posted (Estimated)

April 24, 2002

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

April 17, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020179
  • 02-C-0179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

IPD Sharing Time Frame

Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe