Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
NCT ID: NCT00026884
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5950 participants
OBSERVATIONAL
1998-03-12
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Family Members
Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder
No interventions assigned to this group
Patients
Patients with biopsy-proven malignant diseases; or patients suspected of having a malignant disease; or patients who have or who are suspected of having an inherited genitourinary malignant disorder
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
2 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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W. Marston Linehan, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Role: primary
References
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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.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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97-C-0147
Identifier Type: -
Identifier Source: secondary_id
970147
Identifier Type: -
Identifier Source: org_study_id
NCT00897585
Identifier Type: -
Identifier Source: nct_alias