Collection of Blood From Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00034216
First received: April 24, 2002
Last updated: October 4, 2014
Last verified: April 2014
  Purpose

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
Prostate Cancer
Breast Cancer
Colon Cancer
Lung Cancer
Liver Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Blood, Tissue and Urine From Patients With Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Analyze tissue, urine, saliva, and blood components, which include serum, leukocytes, and circulating tumor cells (cTC), of patients with cancer [ Time Frame: On-going ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the immunologic status of patients with muscle invasive bladder cancer at baseline during and after chemotherapy and post surgery to determine the best time to initiate concurrent or sequential immunotherapy [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Correlate the immunologic subsets in blood with those present in tumor tissue [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Assess the differences in immunologic subsets found with standard gemcitabine and cisplatin with those in dose dense gemcitabine and cisplatin [ Time Frame: On-going ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2002
Detailed Description:

Patients with a prior diagnosis of malignancy or refractory cancer will be evaluated in the Medical Oncology Clinic, NCI or Interventional Radiology, NIH Clinical Center. Blood, urine or saliva samples may be collected at the initial visit and at follow-up visits. The specimens will be processed and stored in one or more of these locations for use in research efforts: Laboratory of Tumor Immunology and Biology, Clinical Pharmacology Program, NCI

Frederick, Dr. Tito Fojo s laboratory and Dr. Jane Trepel s Laboratory.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Patients with malignancy are eligible.

INCLUSION FOR APHERESIS:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034216

Contacts
Contact: Sheri A McMahon, R.N. (301) 496-9812 smcmahon@mail.nih.gov
Contact: James L Gulley, M.D. (301) 496-4916 gulleyj@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
Investigators
Principal Investigator: James L Gulley, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00034216     History of Changes
Other Study ID Numbers: 020179, 02-C-0179
Study First Received: April 24, 2002
Last Updated: October 4, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Breast Neoplasms
Liver Neoplasms
Prostatic Neoplasms
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Liver Diseases
Neoplasms
Neoplasms by Site
Prostatic Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014