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Collection of Blood From Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00034216
Recruitment Status : Recruiting
First Posted : April 24, 2002
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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
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 Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biospecimen Acquisition From Human Subjects
Study Start Date : April 19, 2002

Group/Cohort
Patients
Patients with cancer 18 years of age and older
Healthy Volunteers
Healthy volunteers 18 years of age and older



Primary Outcome Measures :
  1. 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. [ Time Frame: 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.

  2. Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes. [ Time Frame: Ongoing ]
    Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.

  3. Undertake genetic analysis of both prokaryotic and eukaryoticsamples for advanced mutational analysis. [ Time Frame: Ongoing ]
    Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical; healthy volunteers may include NIH employees
Criteria
  • INCLUSION CRITERIA:

Patients 18 years of age and older are eligible.

Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.

INCLUSION FOR APHERESIS:

Effective with Amendment CC, patients 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034216


Contacts
Contact: Sheri A McMahon, R.N. (240) 760-7968 smcmahon@mail.nih.gov
Contact: Jennifer L Marte, M.D. (301) 496-7214 martej@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jennifer L Marte, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00034216     History of Changes
Other Study ID Numbers: 020179
02-C-0179
First Posted: April 24, 2002    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 5, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Suppressor Cells
T-cells
CD4+/CD25+ Cells
Cancer
Malignancy
Blood Sample

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases