Renal CancerNCT00656955
Follow-Up Study of Kidney Cancer Patients
An observational study of Renal Cancer, run by National Cancer Institute (NCI) at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cancer
- How many people
- 1,002 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Apr 2008to 17 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal cancer patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Czechia2 sites
Dept of Cancer Epidemioology Genetics, Brno, CZ
Brno
Olomouc University
Olomouc
About this study
Official title: 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.
Read more
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.
Read the detailed 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.
- Conditions
- Renal Cancer
- Keywords
- Kidney Cancer, Molecular Epidemiology, Survival, Occupational Exposures, Renal Cancer
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal cancer patients | Renal cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Cause-specific and overall mortality
Measured: Months of cancer-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study start17 Apr 2008
- Primary completion31 May 2013
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark P Purdue, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656955
- Sponsor's protocol ID
- 999908107
- Other IDs
- 08-C-N107
- Status last verified
- Jun 2020
- First submitted
- 11 Apr 2008
- Last updated
- 18 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Kidney Cancer Patients From the Central European Multicenter Case-Control Study
- ClinicalTrials.gov ID
- NCT00656955
- Acronym / sponsor ID
- 999908107
- Conditions
- Renal Cancer
- Keywords
- Kidney Cancer, Molecular Epidemiology, Survival, Occupational Exposures, Renal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Apr 2008 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal cancer patients | – | –Renal cancer patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal cancer patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: Months of cancer-free survival
Cause-specific and overall mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P Purdue, M.D. principal investigator
National Cancer Institute (NCI)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer, run by National Cancer Institute (NCI) at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Months of cancer-free survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.