Genetic Susceptibility to Kidney Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

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:

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All
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


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

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 August 18, 2017

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