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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 This content is being retained for historical reference.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:

Children will not be eligible.


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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

Clinical Trials Number:

NCT00034216

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