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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06369519
Other study ID # 2023#17-23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2000
Est. completion date December 31, 2020

Study information

Verified date April 2024
Source Peking University First Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3677
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Surgery treatment or local tumor destruction.
Surgery treatments mainly include partial nephrectomy and radical nephrectomy. Local tumor destruction mainly includes renal mass ablation.

Locations

Country Name City State
China Peking University First Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) 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 Cancer-specific survival (CSS) 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.
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