Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1750 participants
OBSERVATIONAL
2002-07-16
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Volunteers
Healthy volunteers 18 years of age and older
No interventions assigned to this group
Participants
Participants with cancer 18 years of age and older
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jennifer L Marte
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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National Cancer Institute Referral Office
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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020179
Identifier Type: -
Identifier Source: org_study_id
02-C-0179
Identifier Type: -
Identifier Source: secondary_id