Genetic Susceptibility to Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00854022
First received: February 26, 2009
Last updated: December 2, 2010
Last verified: December 2010
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Susceptibility to Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Biospecimen Retention:   Samples With DNA

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Seth P. Lerner, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00854022     History of Changes
Other Study ID Numbers: H-17150
Study First Received: February 26, 2009
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014