Collection of Blood From Patients With Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT00034216

Collaborator

(none)

1,500

Enrollment

Location

Study Details

Study Description

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.

...

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Breast Cancer Colon Cancer Lung Cancer Liver Cancer

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:

Subject 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 Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Biospecimen Acquisition From Human Subjects

Actual Study Start Date :

Jul 16, 2002

Arms and Interventions

Arm	Intervention/Treatment
Healthy Volunteers Healthy volunteers 18 years of age and older
Participants Participants with cancer 18 years of age and older

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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