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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 : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort
Family members
Family members (related by blood or marriage) of patients who have or are suspected of having an inherited genitourinary disorder or a malignancy.
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 urologic malignant disorder.


Outcome Measures
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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
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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 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 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
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 wl3e@nih.gov

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

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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: October 5, 2020
Last Verified: June 12, 2020
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:
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Neoplasms
Kidney Neoplasms
Neoplastic Syndromes, Hereditary
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Urologic Diseases
Kidney Diseases
Genetic Diseases, Inborn