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Follow-Up Study of Kidney Cancer Patients

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), April 2008

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00656955
  Purpose

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.


Condition
Kidney Cancer
Renal Cell Cancer

MedlinePlus related topics:   Cancer    Kidney Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other
Official Title:   Follow-up of Kidney Cancer Patients From the Central European Multicenter Case-Control Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   1097
Study Start Date:   April 2008

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   29 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • 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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656955

Contacts
Contact: Wong-Ho Chow, Ph.D.     (301) 435-4708     choww@mail.nih.gov    

Locations
France
International Agency for Research on Cancer     Recruiting
      Lyon, France

Sponsors and Collaborators
  More Information

Publications:

Study ID Numbers:   999908107, 08-C-N107
First Received:   April 11, 2008
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00656955
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Survival Study  
Kidney Cancer  
Renal Cell Cancer  
Tumor Markers  
Heterogeneity
Kidney Cancer
Survival Study

Study placed in the following topic categories:
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer
Kidney Diseases
Kidney cancer
Urologic Neoplasms
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 05, 2008




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