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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 November 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00026884
First received: November 14, 2001
Last updated: November 18, 2016
Last verified: November 2016
  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
Kidney Cancer
Renal Cancer

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 ]
  • Investigate molecular genetic basis of urologic malignancies. [ Time Frame: On-going ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
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.
  • Investigate molecular genetic basis of urologic malignancies

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.
  • Family members of patients suspected of having an inherited genitourinary malignancy
  • Family members of patients with a DNA variant

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.
  • 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.
  • Germline and somatic whole genome exome sequencing may be performed
  Eligibility

Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  • Family members of patients suspected of having an inherited genitourinary malignancy

EXCLUSION CRITERIA:

  • Subjects whose co-morbidities preclude surgical intervention.
  • Subjects or legally authorized representative unable or unwilling 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. (240) 760-6245 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: W. Marston Linehan, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
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: November 18, 2016
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms
Neoplastic Syndromes, Hereditary
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 02, 2016