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

August 2, 2024 updated by: GONG Kan, Peking University First Hospital

Risk-based Screen and Prognostic Analysis for Second Primary Malignancies in Kidney Cancer Patients: A Retrospective Cohort Study Based on Large-scale Population and Mendelian Randomization Analysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

72408

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

Retrospectively reviewing data were obtained from the Surveillance, Epidemiology, and End Results (SEER) database (https://seer.cancer.gov/) from 2000-2020 using SEER Stat 8.4.1. 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 kidney cancer patients were identified from the SEER database.

Description

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developing a second primary malignancy (SPM)
Time Frame: 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.
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.
Overall survival (OS)
Time Frame: 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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-specific survival (CSS)
Time Frame: 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.
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.

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

July 27, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024#07-03

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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