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Follow-Up Study of Kidney Cancer Patients
This study is currently recruiting participants.
Study NCT00656955   Information provided by National Institutes of Health Clinical Center (CC)
First Received: April 11, 2008   Last Updated: August 24, 2009   History of Changes

April 11, 2008
August 24, 2009
April 2008
April 2010   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00656955 on ClinicalTrials.gov Archive Site
 
 
 
Follow-Up Study of Kidney Cancer Patients
Follow-up of Kidney Cancer Patients From the Central European Multicenter Case-Control Study

Background:

In Central Europe, mortality rates for kidney cancers are higher and survival rates are lower than in the United States and Western Europe overall.

The Central and Eastern European Renal Cancer Case-Control Study (CEERCC), completed in 2002, offers an opportunity to identify determinants that predict 5-year survival among kidney cancer patients.

Objectives:

To assess disease recurrence and progression among former participants in the CEERCC.

To investigate the effect of genetics, lifestyle factors, medical conditions, occupation and diet on the outcome of kidney cancer patients in Europe.

Eligibility:

Former participants or next-of-kin of former participants in the CEERCC study.

Design:

Participants or their next-of-kin are interviewed for 60 minutes and are requested permission to collect relevant information from their or their family member's hospital and cancer registry records.

We propose to conduct a follow-up study of kidney cancer in the high risk region of Central and Eastern Europe. This study would be conducted through the follow-up of a group of patients with kidney cancer that were previously enrolled in the study entitled Occupation, Genetic Susceptibility Kidney Cancer: Central European Case-Control Study, PI Dr. Wong-Ho Chow, OEEB, DCEG, NCI, protocol No. 01-C-N063, a study which is currently out of the field and for which data analyses of the main study are complete. Like the case-control study, the follow-up study would be conducted in six countries, including Romania, Hungary, Poland, Russia, and the Czech Republic. In each study center, cancer-related information will be extracted from vital statistics, cancer registry, and/or medical records to be linked with the previous patient series. If they agree, or if their next-of-kin agrees under the circumstance that the patients are deceased, they or their next-of-kin will also be interviewed with a brief questionnaire. The overall aim is to investigate the role of established and potential determinants of survival by abstracting information from vital statistics, cancer registries, and medical records and by interviewing participating cancer cases or their next-of-kin when possible. We also plan to investigate the role of genetic factors that we hypothesize will affect prognosis and survival among these patients.

First, we will conduct a pilot study to determine the feasibility of collecting survival information including 5-year survival status, date of death, cause of death, and date of last follow-up if alive on 220 cases from the six collaborating centers. Information on 50 cases will be obtained from Olomouc and Moscow and 30 cases from the remaining centers (Bucharest, Prague, Brno, Lodz), using a list of cases provided by the NCI. The feasibility of abstracting additional information including surgical and medical treatment procedures used to treat primary disease, recurrence and progression of primary disease will also be determined. Abstracted information collected and translated into English, in addition to a report describing any obstacles to obtaining information requested will be provided by IARC to the NCI. If we can obtain information from 80% of cases in the feasibility study, we will proceed with the full survival study. The objectives of the main study are: (1) to assess the 5-year survival status of kidney cancer patients in the CEERCC study; (2) to assess prevalence of recurrent disease and progression; (3) to investigate additional patient-, tumor- and genetic determinants of 5-years survival in cases.

 
Observational
Other
  • Kidney Cancer
  • Renal Cell Cancer
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1097
 
April 2010   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

To be eligible for this study, patients needed to have participated as a histologically confirmed renal cancer case in the previous case-control study entitled Central European Renal Cancer Case-Control (CEERCC) Study which was completed in 2002.

EXCLUSION CRITERIA:

Children less than 18 are not eligible to participate in this study because there were no kidney cancer cases observed in the CEERCC Study that were less than 18 years of age.

American Indian/Alaskan Native, Asian, Black or African American, Hispanic or Latino, and Native Hawaiian or Pacific Islander.

Both
29 Years and older
No
Contact: Wong-Ho Chow, Ph.D. (301) 435-4708 choww@mail.nih.gov
France
 
NCT00656955
 
999908107, 08-C-N107
National Cancer Institute (NCI)
 
 
National Institutes of Health Clinical Center (CC)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP