Impact of 10 Different Prior Cancer History on Survival of Patients Who Underwent Surgery for Second Primary Colorectal Cancer: a Population-based Cohort Study

December 19, 2023 updated by: Gao-Min Chen, Guangzhou Medical University

Master's Student in Gastrointestinal Surgery at the First Affiliated Hospital of Guangzhou Medical University

In this study, the investigators collected data with the SEER*Stat software version 8.4.1 (accession number: 20377-Nov2021). The patients with confirmed diagnoses of CRC (site code C18.0-20.9 and C26.0) between 2004 and 2013 were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database. Due to the significant disparity in the number of cancer survivors with various prior cancer types among newly diagnosed CRC patients, the investigators utilized the International Classification of Diseases for Oncology, 3rd edition (ICD-O-3) Site Recode to identify 10 common previous cancer sites, including the colorectum, prostate, breast, uterus, bladder, skin, lung, kidney, thyroid, and stomach. CRC patients with a prior history of cancer originated from one of the 10 sites and surgical CRC patients without a prior history of cancer were enrolled in this study. The exclusion criteria were as follows: (1) Patients with more than one cancer in the past; (2) The patient's age at diagnosis was <18 years old; (3) Patients with incomplete survival data and follow-up information; (4) Patients only had autopsy or death certificate records.

The primary outcomes of this study were overall survival (OS) and cancer-specific survival (CSS). OS was defined as the time from diagnosis to date of death（patients who were still alive at the end of follow-up were considered as censored data. CSS was defined as the time from diagnosis to date of death caused by CRC (patients who deaths from other causes or still alive at the end of follow-up were considered as censored data). The investigators set December 31, 2018, as the cut-off date for follow-up to ensure that all included cases (diagnosed in 2004-2013) were followed for at least 5 years.

Based on prior cancer history, the surgical cases were categorized into two groups: 'Non-prior cancer history' and 'Prior cancer history.' The 'Prior cancer history' group was further subcategorized by the type of prior cancer, including colorectum, prostate, breast, uterus, bladder, skin, lung, kidney, thyroid and stomach. The bias between different Prior cancer history group and Non-prior cancer history group was minimized by Propensity Score Matching (PSM), and the Kaplan-Meier method and log-rank tests were used to compare OS and CSS differences. And then, a multivariate Cox proportional hazards model was performed to estimate the hazard ratios (HR) and 95% confidence interval (CI) to analyze whether different types of prior cancer history impacted the OS and CSS in patients who underwent surgery for spCRC independently. Common demographic and clinicopathological data, including age at diagnosis of spCRC, sex, race, marital status, tumor location of spCRC, pathologic grade of spCRC, TNM stage of spCRC (0-I, II-III, IV and unknown) and chemotherapy status were entered as covariates. Kaplan-Meier curves were also constructed according to the time since first cancer diagnosis (latency), age diagnosed with spCRC, and spCRC stage.

Further analysis was performed to determine the impact of surgery on survival of spCRC patients with different type of prior cancer history. The investigators divided patients into surgical and non-surgical groups based on whether surgery was performed, and then assessed the effect of surgery on survival using the propensity score-adjusted Kaplan-Meier method.

In this study, the baseline characteristics of patients were compared using Chi-square test and Fisher's exact test. A one-to-one propensity score matching (PSM) was performed to reduce the selection bias of the two groups of baseline variables. When performing one-to-one propensity score matching between the prior cancer history group and the non-prior cancer history group, the investigators chose a caliper of 0.2. However, the investigators opted for different calipers when matching the surgical and non-surgical groups because the investigators believe that patients with different prior cancers were in entirely different situations. A two-sided probability value of P ≤ 0.05 was considered statistically significant. R software (version 4.2.3) was used for all statistical analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82770

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University

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

Yes

Sampling Method

Probability Sample

Study Population

We used population-based data from the 9 oldest SEER areas, which represented approximately 9% of the US population.

Description

Inclusion Criteria:

  • confirmed diagnoses of CRC (site code C18.0-20.9 and C26.0)
  • Diagnosis Year between 2004 and 2013

Exclusion Criteria:

  • Patients with more than one cancer in the past
  • The patient's age at diagnosis was <18 years old
  • Patients with incomplete survival data and follow-up information
  • Patients only had autopsy or death certificate records

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
Without prior cancer
With prior colorectal cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior prostate cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior breast cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior uterine cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior bladder cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior skin cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior lung cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior kidney cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior thyroid cancer history
Other: different prior cancer history type
different types of prior cancer history
With prior stomach cancer history
Other: different prior cancer history type
different types of prior cancer history

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: From the initial diagnosis of colorectal cancer, at the end of each month
OS was defined as the time from diagnosis to date of death（patients who were still alive at the end of follow-up were considered as censored data）.
From the initial diagnosis of colorectal cancer, at the end of each month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cancer-specific survival (CSS)
Time Frame: From the initial diagnosis of colorectal cancer, at the end of each month
CSS was defined as the time from diagnosis to date of death caused by CRC (patients who deaths from other causes or still alive at the end of follow-up were considered as censored data)
From the initial diagnosis of colorectal cancer, at the end of each month

Collaborators and Investigators

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

Sponsor

Guangzhou Medical University

Investigators

  • Principal Investigator: Gao-Min Chen, The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 2, 2023

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 12, 2023

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMChen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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