Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
2 other identifiers
observational
5,950
1 country
1
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....
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 1998
CompletedFirst Submitted
Initial submission to the registry
November 14, 2001
CompletedFirst Posted
Study publicly available on registry
November 15, 2001
CompletedMay 1, 2026
April 23, 2026
November 14, 2001
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Investigate quality of life in men who have prostate cancer.
Prostate cancer participants that have improvement in quality of life
on-going
Investigate molecular genetic basis of urologic malignancies
Investigate molecular genetic basis of urologic malignancies
on-going
Investigate cellular/biochemical response to existing and novel therapeutic agents.
Collection of blood, urine, saliva, and/or benign and malignant tissue
on-going
Examine protein expression and bioimmunoassays investigating potential genetic markers.
Detection and expression analysis of gene(s)
on-going
Determine the molecular genetic differences between normal and tumorigenic tissues.
Molecular genetic differences between normal and tumorigenic tissues
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
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
on-going
Study Arms (2)
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
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- Individuals whose co-morbidities preclude surgical intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
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.
PMID: 37404084DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
W. Marston Linehan, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2001
First Posted
November 15, 2001
Study Start
March 12, 1998
Last Updated
May 1, 2026
Record last verified: 2026-04-23
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
- Access Criteria
- Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.
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.