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Completed

NCT Number: NCT00656955

Follow-Up Study of Kidney Cancer Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Cancer Epidemioology Genetics, Brno, CZ, Brno, Czechia

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About this study

Previously we proposed to conduct a follow-up study of kidney cancer in the high risk region of Central and Eastern Europe. This study was 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-Controls Study, PI Dr. Wong-Ho Chow, OEEB, DCEG, NCI, protocol No 01-C-NO63, a study for which field work and data analyses of the case control study were completed. We had originally planned to conduct the follow-up study in seven centers in four countries, including Romania, Poland, Russia, and the Czech Republic. In each center, cancer-related information was to be extracted from vital statistics, cancer registry, and/or medical records. For deceased patients, next-of-kin were to be interviewed using a brief questionnaire.

A pilot study was conducted 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 from 220 cases across the seven collaborating centers. The feasibility of extracting additional data including surgical and medical treatment procedures used to treat primary disease, the recurrence and progression of primary disease was also determined. However, based on results obtained from the pilot study, we determined that it is feasible to collect follow-up data from kidney cancer cases from four centers in the Czech Republic and one center in both Poland and Russia.

Medical records/archives for Romanian cases were located in hospitals that were completely destroyed during reconstruction therefore, it was impossible to collect any information from this subset of patients. Exclusion of these records will not affect study power since most of the cases were from the Czech Republic. The objective of our proposed study remains the same:( 1) to assess the 5-year survival status of kidney cancer patients in the Central and Easter European Renal Cell Carcinoma Study; (2) to examine prevalence of recurrent disease and progression; (3) to investigate additional patient-tumor-and genetic determinant of 5-year survival in cases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: Months of cancer-free survival

    Cause-specific and overall mortality

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Follow-up of Kidney Cancer Patients From the Central European Multicenter Case-Control Study

Important dates

Study start
2008
Primary completion
2013
Study completion
2020
First posted
Apr 14, 2008
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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