Risk-based Screen and Prognostic Analysis for Second Primary Malignancies in Kidney Cancer Patients

Completed

• Conditions: Kidney Cancer
• Interventions: Procedure: Surgery, radiation therapy and chemotherapy

• Registration Number: NCT06531629
• Lead Sponsor: Peking University First Hospital

Brief Summary

Second primary malignancy (SPM) significantly impacts the survival and prognosis of patients. This study endeavors to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct predictive nomograms.

Detailed Description

In recent years, with the advancement of cancer treatment techniques and the prolonged survival of patients, the prevalence of Second primary malignancy (SPM) has been escalating, emerging as a significant health issue among cancer survivors. The goal of this study is to identify risk and prognostic factors associated with SPM after first primary kidney cancer and construct nomograms to provide clinical evidence. The main questions this study aims to answer are: (1) What are the risk factors associated with the prevalence of SPM after kidney cancer? (2) What are the prognostic factors associated with the overall survival (OS) of kidney cancer patients with SPM? (3) How to accurately predict the probability of developing SPM after kidney cancer and the OS of kidney cancer patients with SPM? In this retrospective population-based cohort study, Patients diagnosed with first primary kidney cancer between 2000 and 2020 were retrospectively enrolled from the Surveillance, Epidemiology, and End Results (SEER) database. Researchers will concentrate on the risk and prognostic factors of SPM after kidney cancer, and develop nomograms to forecast the development and overall survival (OS) of SPM after kidney cancer.

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2024-07-27
• Study First Submitted QC: 2024-07-30
• Status Verified: 2024-08
• Study First Posted: 2024-08-01
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72408

Inclusion Criteria

• (1) Diagnosed age was between 18 and 80 years old
• (2) Diagnosed histologically confirmed as first primary kidney cancer
• (3) The staging of kidney cancer was early or localized advanced (T1/2/3N0M0)
• (4) Detailed survival data and follow-up information should be provided

Exclusion Criteria

• (1) Histological conformation for diagnosis was unavailable
• (2) The type of reporting source was "Death certificate only" or "Autopsy only"
• (3) Patients with other malignancies before the diagnosis of primary kidney cancer
• (4) The staging of kidney cancer was not early or localized advanced (T1/2/3N0M0)
• (5) Diagnosis interval between first primary malignancy (FPM) and second primary malignancy (SPM) was less than 6 months
• (6) The information was not complete

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney cancer patients without SPM	Surgery, radiation therapy and chemotherapy	Patients diagnosed with only first primary kidney cancer between 2000 and 2020
Kidney cancer patients with second primary malignancy (SPM)	Surgery, radiation therapy and chemotherapy	Patients diagnosed with first primary kidney cancer and second primary malignancy between 2000 and 2020

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	From the date of diagnosis of the second primary malignancy to the date of death from any cause or the data 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 malignancy to death or the time to the last follow-up.
Developing a second primary malignancy (SPM)	This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy, assessed up to 20 years.	This time was calculated as the time interval from the diagnosis of first primary kidney cancer to the diagnosis of second primary malignancy.

Secondary Outcome Measures

Name	Time	Method
Cancer-specific survival (CSS)	From date of diagnosis of the second primary malignancy 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 malignancy to death from the same disease or the last follow-up.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China