Clinical trial NCT00034216: Collection of Blood From Patients With Cancer
Official title: Biospecimen Acquisition From Human Subjects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Breast Cancer
Colon Cancer
Lung Cancer
Liver Cancer
Keywords: Suppressor Cells
T-cells
CD4+ / CD25+ cells
Natural History
Cancer
Malignancy
Blood Sample
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-04-24
Enrollment: 1750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary clinical; healthy volunteers may include NIH employees

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.

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:

- 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
timeFrame: ongoing
measure: Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
timeFrame: ongoing
measure: 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.
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Jennifer L Marte
role: PRINCIPAL_INVESTIGATOR
References: