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

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ClinicalTrials.gov Identifier: NCT00026884

Recruitment Status : Recruiting

First Posted : November 15, 2001

Last Update Posted : January 25, 2023

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Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description

Brief Summary:

Selected patients 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.

Condition or disease
Malignant Neoplasms Hereditary Neoplastic Syndromes Kidney Cancer Renal Cancer Bladder Cancer

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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

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

Study Design

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Study Type :	Observational
Estimated Enrollment :	5000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases
Actual Study Start Date :	March 12, 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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
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

Outcome Measures

Primary Outcome Measures :

Investigate quality of life in men who have prostate cancer. [ Time Frame: on-going ]
Prostate cancer patients that have improvement in quality of life
Investigate molecular genetic basis of urologic malignancies [ Time Frame: on-going ]
Investigate molecular genetic basis of urologic malignancies
Investigate cellular/biochemical response to existing and novel therapeutic agents. [ Time Frame: on-going ]
Collection of blood, urine, saliva, and/or benign and malignant tissue
Examine protein expression and bioimmunoassays investigating potential genetic markers. [ Time Frame: on-going ]
Detection and expression analysis of gene(s)
Determine the molecular genetic differences between normal and tumorigenic tissues. [ Time Frame: on-going ]
Molecular genetic differences between normal and tumorigenic tissues
Collection of benign and malignant tissue from patients with rare inherited conditions associated with an increased risk for kidney cancer. [ Time Frame: on-going ]
Collection of blood, urine, saliva, and/or benign and malignant tissue
Collection of benign and malignant tissue from patients with known or suspected cancer. [ Time Frame: on-going ]
Collection of blood, urine, saliva, and/or benign and malignant tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

1. Patients with biopsy-proven malignant disease 2. Patients suspected of having malignant disease 3. Patients with known or suspected urologic malignant disorders who have clinically indicated urologic or non-urologic surgical lesion 4. Family members of patients suspected of having an inherited genitourinary malignancy 5. Family members of patients with a DNA variant

Criteria

INCLUSION CRITERIA:
Adult and minor patients with biopsy-proven malignant disease
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 adults unable to consent or 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:

- Subjects whose co-morbidities preclude surgical intervention.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026884

Contacts

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Contact: Deborah A Nielsen, R.N.	(240) 760-6247	deborah.nielsen@nih.gov
Contact: W. Marston Linehan, M.D.	(240) 858-3700	linehanm@mail.nih.gov

Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	W. Marston Linehan, M.D.	National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

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Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00026884
Obsolete Identifiers:	NCT00897585
Other Study ID Numbers:	970147 97-C-0147
First Posted:	November 15, 2001 Key Record Dates
Last Update Posted:	January 25, 2023
Last Verified:	November 9, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	.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 Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):


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

Additional relevant MeSH terms:

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Neoplasms Kidney Neoplasms Neoplastic Syndromes, Hereditary Urologic Neoplasms Urogenital Neoplasms	Neoplasms by Site Urologic Diseases Kidney Diseases Genetic Diseases, Inborn

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