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Genetic Susceptibility to Kidney Cancer
This study is currently recruiting participants.
Verified by Baylor College of Medicine, March 2009
First Received: February 26, 2009   Last Updated: March 2, 2009   History of Changes
Sponsors and Collaborators: Baylor College of Medicine
M.D. Anderson Cancer Center
Information provided by: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00854022
  Purpose

This study will further the understanding of the genetic events leading to the development of RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and eventually provide a means of identifying a subgroup of individuals who are most likely to develop RCC. Such individuals may then be targeted for intervention programs such as chemoprevention or dietary modification.


Condition
Renal Cell Carcinoma

MedlinePlus related topics: Cancer Kidney Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Genetic Susceptibility to Renal Cell Carcinoma

Further study details as provided by Baylor College of Medicine:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

We will utilize the blood collected to run several laboratory analyses that will assess DNA damage/repair, telomere length, telomerase activity, and other genetic instability as predictors of RCC risk. All information linking this unique identifier to the participant will be kept in a secure location under lock-and-key password protected.

In addition, RCC tumor and adjacent normal tissue samples may be obtained from the MDACC Institutional Tissue Bank (ITB) for cases only. The samples obtained will be left over from surgical procedures, so as to prevent any additional distress to the patient.


Estimated Enrollment: 1600
Study Start Date: July 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy
Healthy adults, of any ethnicity, or sex, and with no previous history of cancer, except for non-melanoma skin cancer
RCC
Adult patients with newly diagnosed (diagnosed within the year of enrollment) renal carcinoma (RCC) any ethnicity, or sex, who have not received prior chemotherapy or radiotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with newly diagnosed (diagnosed within the year of enrollment) with possible Renal Cell Carcinoma (RCC)

Criteria

Inclusion Criteria:

  • Adult patients of any ethnicity or sex, who have a been diagnosed with possible Renal Cell Carcinoma within the past year.

Exclusion Criteria:

  • Must not have received chemotherapy, biological therapy or radiation therapy in the 6 months preceding enrollment will
  • Must not have had RCC, or metastatic RCC,
  • Must not have had a renal transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854022

Contacts
Contact: Carmen Bedford 713-798-2179 bedford@bcm.edu

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: XIFENG WU     713-745-2485     xwu@mdanderson.org    
Sub-Investigator: Richard E. Link, MD, PhD            
Sub-Investigator: Brian J. Miles, MD            
Sponsors and Collaborators
Baylor College of Medicine
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Baylor College of Medicine ( Seth P. Lerner, MD )
Study ID Numbers: H-17150
Study First Received: February 26, 2009
Last Updated: March 2, 2009
ClinicalTrials.gov Identifier: NCT00854022     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Disease Susceptibility
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Genetic Predisposition to Disease
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Disease Attributes
Neoplasms by Histologic Type
Disease Susceptibility
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Neoplasms
Pathologic Processes
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Genetic Predisposition to Disease
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009