NCT00034216

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,750

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2002

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 24, 2002

Completed
3 months until next milestone

Study Start

First participant enrolled

July 16, 2002

Completed
Last Updated

April 21, 2026

Status Verified

April 17, 2026

First QC Date

April 24, 2002

Last Update Submit

April 18, 2026

Conditions

Breast CancerColon CancerLung CancerLiver CancerProstate Cancer

Keywords

Suppressor CellsT-cellsCD4+ / CD25+ cellsNatural HistoryCancerMalignancyBlood Sample

Outcome Measures

Primary Outcomes (3)

  • Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.

    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.

    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.

    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

Study Arms (2)

Healthy Volunteers

Healthy volunteers 18 years of age and older

Participants

Participants with cancer 18 years of age and older

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary clinical; healthy volunteers may include NIH employees

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsBreast NeoplasmsColonic NeoplasmsLung NeoplasmsLiver NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesLiver Diseases

Study Officials

  • Jennifer L Marte

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michell J Manu, R.N.

CONTACT

(240) 529-3415michell.manu@nih.gov

Jennifer L Marte

CONTACT

(301) 496-7214martej@mail.nih.gov

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2002

First Posted

April 24, 2002

Study Start

July 16, 2002

Last Updated

April 21, 2026

Record last verified: 2026-04-17

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.
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.

Locations

US(1)