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


N/A
N/A
N/A
Open (Enrolling)
Both
Neoplasm

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

W. Marston Linehan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

970147

NCT ID:

NCT00026884

Start Date:

July 1997

Completion Date:

Related Keywords:

  • Neoplasm
  • Tissue Procurement
  • Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892