Follow-Up Study of Kidney Cancer Patients

Renal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656955
• Other study ID #: 999908107
• Secondary ID: 08-C-N107
• Status: Completed
• Start date: April 17, 2008
• Est. completion date: June 17, 2020

Study information

• Verified date: June 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: June 17, 2020
• Est. primary completion date: May 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

Locations

Country	Name	City	State
Czechia	Dept of Cancer Epidemioology Genetics, Brno, CZ	Brno
Czechia	Olomouc University	Olomouc
Poland	National Institute of Occupational Medicine, Lodz, Poland	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Cause-specific and overall mortality	Months of cancer-free survival