Protocol Details

Biospecimen Acquisition from Human Subjects

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	02-C-0179
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children; Adults who are or may become unable to consent; Pregnant Women; Fetuses; Neonates
Keywords	Suppressor Cells; T-cells; CD4+ / CD25+ cells; Natural History
Recruitment Keyword(s)	Cancer; Malignancy; Blood Sample
Condition(s)	Prostate Cancer; Breast Cancer; Colon Cancer; Lung Cancer; Liver Cancer
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

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.

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Eligibility

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 This content is being retained for historical reference.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.

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
Jennifer L. Marte National Cancer Institute (NCI) National Institutes of Health Building 10 Room 13N208 10 Center Drive Bethesda, Maryland 20892 (301) 496-7214 martej@mail.nih.gov	Sheri A. McMahon, R.N. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 13N254 10 Center Drive Bethesda, Maryland 20892 (240) 760-7968 sheri.mcmahon@nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937 ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT00034216

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