Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00026884
First received: November 14, 2001
Last updated: July 23, 2014
Last verified: June 2014
  Purpose

Selected patients suspected of having or with prior biopsy proof of malignant disease will be seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the initial visit and at periodic intervals during the course of the disease. These samples will be stored in the tissue bank of the Urologic Oncology Branch. Aliquots of malignant and normal tissue will be collected at the time of surgery and stored in the tissue bank, Urologic Oncology Branch, NCI. These materials will be used in the research efforts of the Urologic Oncology Branch, NCI.


Condition
Malignant Neoplasms
Hereditary Neoplastic Syndromes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Collection of benign and malignant tissue from patients with known or suspected cancer. [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer. [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Determine the molecular genetic differences between normal and tumorigenic tissues. [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Examine protein expression and bioimmunoassays investigating potential genetic markers. [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Investigate cellular/biochemical response to existing and novel therapeutic agents. [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Investigate quality of life in men who have prostate cancer. [ Time Frame: On-going ] [ Designated as safety issue: No ]

Estimated Enrollment: 3500
Study Start Date: July 1997
Detailed Description:

Background

- Kidney, prostate, bladder, testis and penile cancer account for 22% of cancers diagnosed in the United States and are responsible for 10% of cancer deaths each year in the U.S. Understanding the genes and gene pathways that cause genitourinary malignancies will provide the foundation for the development of targeted therapeutic agents for patients affected with these cancers. Since 1982 investigators in the Urologic Oncology Branch have been studying the genetic basis of urologic cancers. The identification of the genes for cancer of the kidney has led to the approval by the FDA of a number of new agents for patients with advanced disease. It is our goal to study the cancer gene pathways of genitourinary malignancies in order to further understand the cancer gene pathways that cause these diseases.

Objectives

  • Collection of benign and malignant tissue from patients with known or suspected cancer.
  • Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer.
  • Determine the molecular genetic differences between normal and tumorigenic tissues.
  • Investigate the categories of genes/ biochemical pathways such as those that influence the cell cycle, angiogenesis, metabolic changes, and metastatic potential.
  • Examine protein expression and bioimmunoassays investigating potential genetic markers.
  • Investigate cellular/biochemical response to existing and novel therapeutic agents.
  • Investigate quality of life in men who have prostate cancer.

Eligibility

  • Patients with biopsy-proven malignant disease.
  • Patients suspected of having malignant disease.
  • Patients with known or suspected urologic malignant disorders who have clinically indicated urologic or non-urologic surgical lesion.

Design

  • Patients will be screened for eligibility in the Urologic Oncology Branch Clinic.
  • Blood and urine samples may be obtained.
  • Normal and malignant tissue may be collected from patients undergoing clinically indicated surgical procedures.
  • Basic scientific research will be performed on collected specimens.
  • Results will not be returned to patients.
  • Patients will have the option to be contacted if a result is detected that would affect their health and they will be given the opportunity to be evaluated and re-tested on an IRB approved protocol if available.
  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Adult and minor patients with biopsy-proven malignant disease.
  • Adult and minor patients suspected of having a malignant lesion.
  • Patients who have or who are suspected of having an inherited urologic malignant disorder.

EXCLUSION CRITERIA:

  • Subjects whose co-morbidities preclude surgical intervention.
  • Subjects unable to provide consent.
  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: NCT00026884

Contacts
Contact: W. Marston Linehan, M.D. (301) 496-6353 wl3e@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: W. Marston Linehan, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00026884     History of Changes
Obsolete Identifiers: NCT00897585
Other Study ID Numbers: 970147, 97-C-0147
Study First Received: November 14, 2001
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Serum
Collection of Tissue
Malignant Disease

Additional relevant MeSH terms:
Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 14, 2014