An observational study in Malignant Neoplasms, Hereditary Neoplastic Syndromes and Kidney Cancer, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by National Cancer Institute (NCI) · Observational
Selected individuals 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.
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
Eligibility
Design
1. Individuals with biopsy-proven malignant disease 2. Individuals suspected of having malignant disease 3. Individuals with known or suspected urologic malignant disorders who have clinically indicated urologic or non-urologic surgical lesion 4. Family members of individuals suspected of having an inherited genitourinary malignancy 5. Family members of individuals with a DNA variant
EXCLUSION CRITERIA:
-Individuals whose co-morbidities preclude surgical intervention.
Family members (related by blood) of participants who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder
Participants with biopsy-proven malignant diseases; or participants suspected of having a malignant disease; or participants who have or who are suspected of having an inherited genitourinary malignant disorder
Investigate quality of life in men who have prostate cancer.
Prostate cancer participants that have improvement in quality of life
Time frame: on-going
Investigate molecular genetic basis of urologic malignancies
Investigate molecular genetic basis of urologic malignancies
Time frame: on-going
Investigate cellular/biochemical response to existing and novel therapeutic agents.
Collection of blood, urine, saliva, and/or benign and malignant tissue
Time frame: on-going
Examine protein expression and bioimmunoassays investigating potential genetic markers.
Detection and expression analysis of gene(s)
Time frame: on-going
Determine the molecular genetic differences between normal and tumorigenic tissues.
Molecular genetic differences between normal and tumorigenic tissues
Time frame: on-going
Collection of benign and malignant tissue from individuals with rare inherited conditions associated with an increased risk for kidney cancer.
Collection of blood, urine, saliva, and/or benign and malignant tissue
Time frame: on-going
Collection of benign and malignant tissue from individuals with known or suspected cancer.
Collection of blood, urine, saliva, and/or benign and malignant tissue
Time frame: on-going
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting information: Study protocol, Sap, Icf
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National Cancer Institute (NCI)