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

• ClinicalTrials.gov Identifier: NCT00026884
• Recruitment Status: Recruiting
• First Posted: November 15, 2001
• Last Update Posted: August 8, 2019
• Sponsor: National Cancer Institute (NCI)
• 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

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

Eligibility

• Patients with biopsy-proven malignant disease.
• Patients suspected of having malignant disease.
• Patients with known or suspected urologic malignant disorders who have clinically indicated urologic or non-urologic surgical lesion.
• Family members of patients suspected of having an inherited genitourinary 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

• 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 Disease
• Actual Study Start Date: March 12, 1998

Groups and Cohorts

Group/Cohort
Family members; Any family members who Suspected of having a malignant lesion
Patients; Any patient with Biopsy-Proved Malignant Diseases

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. Determine the molecular genetic differences between normal and tumorigenic tissues. [ Time Frame: On-going ]
   Molecular genetic differences between normal and tumorigenictissues.
4. Examine protein expression and bioimmunoassays investigating potential genetic markers. [ Time Frame: On-going ]
   Detection and expression analysis of gene(s)
5. 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
6. Investigate quality of life in men who have prostate cancer. [ Time Frame: On-going ]
   Prostate cancer patients that have improvement in quality of life
7. Investigate molecular genetic basis of urologic malignancies. [ Time Frame: On-going ]
   Investigate molecular genetic basis of urologic malignancies

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 100 Years (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 nonurologic 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 lesion
• Patients who have or who are suspected of having an inherited urologic malignant disorder
• Family members of patients suspected of having an inherited genitourinary malignancy

EXCLUSION CRITERIA:

• Subjects whose co-morbidities preclude surgical intervention.
• Subjects are unable or unwilling to provide consent.

Contacts and Locations

Contacts

Contact: Deborah A Nielsen, R.N.; (240) 760-6247; deborah.nielsen@nih.gov

Contact: W. Marston Linehan, M.D.; (240) 760-6245; wl3e@nih.gov

Locations

United States, Maryland

National Institutes of Health Clinical Center, 9000 Rockville Pike; Recruiting

Bethesda, Maryland, United States, 20892

Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00026884 History of Changes
• Obsolete Identifiers: NCT00897585
• Other Study ID Numbers: 970147; 97-C-0147
• First Posted: November 15, 2001
• Last Update Posted: August 8, 2019
• Last Verified: August 6, 2019

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

Serum; Collection of Tissue; Malignant Disease; Molecular Basis; Genome Sequencing

Additional relevant MeSH terms:

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