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RecruitingNCT00026884Updated Sep 30, 2026

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,950
Ages
2 Years and older
Sex
All
01

Study 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.

Read the 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
  • Examine cell free DNA and circulating tumor DNA for cancer gene mutations

Eligibility

  • Individuals with biopsy-proven malignant disease
  • Individuals suspected of having malignant disease
  • Individuals with known or suspected inherited urologic malignant disorder
  • A relative (related by blood) of an individual with a confirmed or suspected diagnosis of an inherited genitourinary disorder or malignancy
  • Family members of patients with a DNA variant

Design

  • Participants 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 participants undergoing clinically indicated surgical procedures
  • Basic scientific research will be performed on collected specimens
  • Participants 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
02

Conditions studied

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

Keywords

  • Serum
  • Collection of Tissue
  • Malignant Disease
  • Molecular Basis
  • Genome Sequencing
  • Natural History
03

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

EXCLUSION CRITERIA:

-Individuals whose co-morbidities preclude surgical intervention.

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,950 participants (estimated)

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

  1. Investigate quality of life in men who have prostate cancer.

    Prostate cancer participants that have improvement in quality of life

    Time frame: on-going

  2. Investigate molecular genetic basis of urologic malignancies

    Investigate molecular genetic basis of urologic malignancies

    Time frame: on-going

  3. 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

  4. Examine protein expression and bioimmunoassays investigating potential genetic markers.

    Detection and expression analysis of gene(s)

    Time frame: on-going

  5. Determine the molecular genetic differences between normal and tumorigenic tissues.

    Molecular genetic differences between normal and tumorigenic tissues

    Time frame: on-going

  6. 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

  7. 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

06

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Contact · 888-624-1937
    Recruiting
07

References and documents

Publications

  • Merriman KM, Harmon SA, Belue MJ, Yilmaz EC, Blake Z, Lay NS, Phelps TE, Merino MJ, Parnes HL, Law YM, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Comparison of MRI-Based Staging and Pathologic Staging for Predicting Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. AJR Am J Roentgenol. 2023 Dec;221(6):773-787. doi: 10.2214/AJR.23.29609. Epub 2023 Jul 5. PubMed 37404084 ↗

Individual participant data

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

08

Registry details

Key details

Study ID
NCT00026884
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 15, 2001
Start date
Mar 12, 1998
Last update
Sep 30, 2026

Study contacts

Deborah A Nielsen, R.N.
Contact
deborah.nielsen@nih.gov
(240) 760-6247
W. Marston Linehan, M.D.
Contact
linehanm@mail.nih.gov
(240) 858-3700
W. Marston Linehan, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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