Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT00034216

Conditions

Prostate Cancer

Breast Cancer

Colon Cancer

Lung Cancer

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

...

Conditions

Prostate Cancer

Breast Cancer

Colon Cancer

Lung Cancer

Liver Cancer

Study ID

NCT00034216

Start date

Jul 16, 2002

Status verified date

Jul 22, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

  • 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 This content is being retained for historical reference.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 Design

Enrollment

1750 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Volunteers

Healthy volunteers 18 years of age and older

Participants

Participants with cancer 18 years of age and older

Primary outcome measure

  • Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis. [ Time Frame: ongoing ]
  • Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes. [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Michell J Manu, R.N.

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

Jennifer L Marte

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937ncimo_referrals@mail.nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 1, 2026

Last verified

Jul 22, 2026

Keywords

  • Suppressor Cells
  • T-cells
  • CD4+ / CD25+ cells
  • Natural History
  • Cancer
  • Malignancy
  • Blood Sample

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-01.