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

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


  • Org Study ID: 970147
  • Secondary ID: 97-C-0147
  • NCT ID: NCT00026884
  • NCT Alias: NCT00897585
  • Sponsor: National Cancer Institute (NCI) - NIH
  • Source: National Institutes of Health Clinical Center (CC)

Brief Summary

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....

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

Overal Status Start Date Phase Study Type
Recruiting Start Date: July 14, 1997 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Collection of benign and malignant tissue from patients with known or suspected cancer.

Primary Outcome 1 - Time Frame: On-going

Primary Outcome 2 - Measure: Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer.

Primary Outcome 2 - Time Frame: On-going

Primary Outcome 3 - Measure: Determine the molecular genetic differences between normal and tumorigenic tissues.

Primary Outcome 3 - Time Frame: On-going

Primary Outcome 4 - Measure: Examine protein expression and bioimmunoassays investigating potential genetic markers.

Primary Outcome 4 - Time Frame: On-going

Primary Outcome 5 - Measure: Investigate cellular/biochemical response to existing and novel therapeutic agents.

Primary Outcome 5 - Time Frame: On-going

Primary Outcome 6 - Measure: Investigate quality of life in men who have prostate cancer.

Primary Outcome 6 - Time Frame: On-going

Primary Outcome 7 - Measure: Investigate molecular genetic basis of urologic malignancies.

Primary Outcome 7 - Time Frame: On-going

Condition:

  • Malignant Neoplasms
  • Hereditary Neoplastic Syndromes
  • Kidney Cancer
  • Renal Cancer
  • Bladder Cancer

Eligibility

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 are unable or unwilling to provide consent.

- Pregnant women are excluded from enrollment onto this study because there is no

direct benefit for participating in the study
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Gender: All

Minimum Age: 2 Years

Maximum Age: 100 Years

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: W. Marston Linehan, M.D.

Role: Principal Investigator

Affiliation: National Cancer Institute (NCI)

Overall Contact

Name: Deborah A Nielsen, R.N.

Phone: (240) 760-6247

Email: deborah.nielsen@nih.gov

Link: NIH Clinical Center Detailed Web Page

Location

Facility Status Contact
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland 20892
United States
Recruiting For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
(888) NCI-1937