Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma

April 12, 2024 updated by: GONG Kan, Peking University First Hospital

Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma: a Population-based Cohort Study

Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:

What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?

Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. This cohort study aims to identify prognostic factors, construct predictive nomograms, and optimize surgical treatment for sporadic BRCC patients. The main questions it aims to answer are:

What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients? In this retrospective population-based cohort study, patients diagnosed with sporadic BRCC between 2000 and 2020 were identified from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments.

Study Type

Observational

Enrollment (Actual)

3677

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study was based on the Surveillance, Epidemiology, and End Results (SEER) database, which contains the population-based data from 17 Registries covering approximately 26.5% of the U.S. population. The eligible sporadic localized BRCC patients were identified from the SEER database.

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Clinical diagnosis of localized BRCC (M0) from 2000 to 2020.
  • Active follow-up.
  • Complete clinicopathological information.

Exclusion Criteria:

  • Diagnosed by autopsy or death certificate only.
  • Tending to suffer from hereditary RCC, including those complicating with pancreatic neuroendocrine tumor (pNET) or hemangioblastoma.
  • Unavailable key information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Synchronous BRCC patients
Synchronous BRCC is defined as the second primary RCC emerges within 6 months from the diagnosis of the first primary RCC.
Procedure: Surgery treatment or local tumor destruction.
Surgery treatments mainly include partial nephrectomy and radical nephrectomy. Local tumor destruction mainly includes renal mass ablation.
Metachronous BRCC patients
Metachronous BRCC develops beyond 6 months from the diagnosis of the first primary RCC.
Procedure: Surgery treatment or local tumor destruction.
Surgery treatments mainly include partial nephrectomy and radical nephrectomy. Local tumor destruction mainly includes renal mass ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of diagnosis of the second primary RCC until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 20 years.
OS was calculated as the time interval from the diagnosis of the second primary RCC to death or the time to the last follow-up.
From date of diagnosis of the second primary RCC until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 20 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-specific survival (CSS)
Time Frame: From date of diagnosis of the second primary RCC until the date of death from the same disease or the date of last follow-up, whichever came first, assessed up to 20 years.
CSS was calculated as the time interval from the diagnosis of the second primary RCC to death from the same disease or the last follow-up.
From date of diagnosis of the second primary RCC until the date of death from the same disease or the date of last follow-up, whichever came first, assessed up to 20 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Kan Gong, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023#17-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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