Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT00026884

Conditions

Malignant Neoplasms

Hereditary Neoplastic Syndromes

Kidney Cancer

Renal Cancer

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Malignant Neoplasms

Hereditary Neoplastic Syndromes

Kidney Cancer

Renal Cancer

Bladder Cancer

Study ID

NCT00026884

Start date

Mar 12, 1998

Status verified date

Aug 26, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • Individuals with biopsy-proven malignant disease
  • Individuals suspected of having a malignant disease
  • Individuals who have or are suspected of having an inherited genitourinary malignant disorder
  • Participants must be >= 2 years of age
  • A relative (related by blood) of an individual with a confirmed or suspected diagnosis of a malignant disease or an inherited genitourinary malignant disorder.
  • All participants and parents/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.

EXCLUSION CRITERIA:

-Individuals whose co-morbidities preclude surgical intervention.

Study Design

Enrollment

5950 participants

Anticipated

Interventions and Outcome Measures

Arms

Family Members

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

Participants

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

Primary outcome measure

  • Investigate quality of life in men who have prostate cancer. [ Time Frame: on-going ]
  • Investigate molecular genetic basis of urologic malignancies [ Time Frame: on-going ]
  • Investigate cellular/biochemical response to existing and novel therapeutic agents. [ Time Frame: on-going ]
  • Examine protein expression and bioimmunoassays investigating potential genetic markers. [ Time Frame: on-going ]
  • Determine the 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. [ Time Frame: on-going ]
  • Collection of benign and malignant tissue from individuals with known or suspected cancer. [ Time Frame: on-going ]

Central Contacts and Locations

Central contacts

Deborah A Nielsen, R.N.

(240) 760-6247deborah.nielsen@nih.gov

W. Marston Linehan, M.D.

(240) 858-3700linehanm@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 28, 2026

Last verified

Aug 26, 2026

Keywords

  • Serum
  • Collection of Tissue
  • Malignant Disease
  • Molecular Basis
  • Genome Sequencing
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-28.