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
Recruitment status was Recruiting
Sponsor:
Baylor College of Medicine
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
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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 (Adult, Senior) |
| 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
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 |
| 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 September 28, 2016