We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Collection of Blood From Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00034216
Recruitment Status : Recruiting
First Posted : April 24, 2002
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date April 24, 2002
First Posted Date April 24, 2002
Last Update Posted Date January 27, 2023
Actual Study Start Date July 16, 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: November 3, 2021)
  • Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis. [ Time Frame: 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. [ Time Frame: 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. [ 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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection of Blood From Patients With Cancer
Official Title Biospecimen Acquisition From Human Subjects
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:

- 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary clinical; healthy volunteers may include NIH employees
Condition
  • Prostate Cancer
  • Breast Cancer
  • Colon Cancer
  • Lung Cancer
  • Liver Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Healthy Volunteers
    Healthy volunteers 18 years of age and older
  • Participants
    Participants with cancer 18 years of age and older
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 20, 2021)
1500
Original Enrollment
 (submitted: June 23, 2005)
100
Study Completion Date Not Provided
Primary Completion Date Not Provided
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:

Children will not be eligible.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sheri A McMahon, R.N. (240) 760-7968 sheri.mcmahon@nih.gov
Contact: Jennifer L Marte (301) 496-7214 martej@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00034216
Other Study ID Numbers 020179
02-C-0179
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Original Responsible Party Not Provided
Current Study Sponsor National Cancer Institute (NCI)
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Jennifer L Marte National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 24, 2023