Collection of Blood From Patients With Cancer

Breast Cancer Clinical Trial

Official title:

Biospecimen Acquisition From Human Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00034216
• Other study ID #: 020179
• Secondary ID: 02-C-0179
• Status: Recruiting
• Start date: July 16, 2002

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Sheri A McMahon, R.N.
• Phone: (240) 760-7968
• Email: sheri.mcmahon[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1750
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Prostate Cancer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page