Collection of Blood From Patients With Cancer

• ClinicalTrials.gov Identifier: NCT00034216
• Recruitment Status: Recruiting
• First Posted: April 24, 2002
• Last Update Posted: January 27, 2023
• Sponsor: National Cancer Institute (NCI)
• 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
• 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

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

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