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NCT Number: NCT06531629

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

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.

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Neoplasms, Second Primary Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery, radiation therapy and chemotherapy

Procedure

Surgery, radiation therapy and chemotherapy

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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