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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00026884
• Other study ID #: 970147
• Secondary ID: 97-C-0147
• Status: Recruiting
• Start date: March 12, 1998

Study information

• Verified date: June 6, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Deborah A Nielsen, R.N.
• Phone: (240) 760-6247
• Email: deborah.nielsen[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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....

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

Examine cell free DNA and circulating tumor DNA for cancer gene mutations

Eligibility

Patients with biopsy-proven malignant disease

Patients suspected of having malignant disease

Patients with known or suspected inherited urologic malignant disorder

Family members (related by blood) of patients who have or are suspected of having an inherited genitourinary disorder or 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

Other known NCT identifiers

• NCT00897585

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5950
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

• INCLUSION CRITERIA:

• Adult and minor patients with biopsy-proven malignant disease

• Adult and minor patients suspected of having a malignant disease

• Patients who have or are suspected of having an inherited genitourinary malignant disorder

• Participants must be >= 2 years of age

• Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder.

• All patients and guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.

EXCLUSION CRITERIA:

• Subjects whose co-morbidities preclude surgical intervention.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate quality of life in men who have prostate cancer.	Prostate cancer patients that have improvement in quality of life	on-going
Primary	Investigate molecular genetic basis of urologic malignancies	Investigate molecular genetic basis of urologic malignancies	on-going
Primary	Investigate cellular/biochemical response to existing and novel therapeutic agents.	Collection of blood, urine, saliva, and/or benign and malignant tissue	on-going
Primary	Examine protein expression and bioimmunoassays investigating potential genetic markers.	Detection and expression analysis of gene(s)	on-going
Primary	Determine the molecular genetic differences between normal and tumorigenic tissues.	Molecular genetic differences between normal and tumorigenic tissues	on-going
Primary	Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer.	Collection of blood, urine, saliva, and/or benign and malignant tissue	on-going
Primary	Collection of benign and malignant tissue from patients with known or suspected cancer.	Collection of blood, urine, saliva, and/or benign and malignant tissue	on-going

External Links

•   NIH Clinical Center Detailed Web Page