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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

82770 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-02

Study Completion Date

2023-11-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EOCRCPred: an AI Model to Predict Survival in EOCRC Patients After Surgery

NCT06690606

Colorectal Cancer

NOT_YET_RECRUITING

Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer

NCT05891301

Patient With Colorectal Cancer Surgery

UNKNOWN

Fecal Metagenomics and Metabolomics Analyses to Identify Potential Screening Biomarkers for Colorectal Polyps and Cancer in Chinese Population

NCT04947930

Colorectal Cancer Colorectal Polyp Mass Screening +1 more

UNKNOWN

The Predictive Value of Guangzhou Panel for Recurrence in Early-stage Colorectal Cancer

NCT03923335

Colorectal Neoplasms

NOT_YET_RECRUITING

The Impact of Colorectal Cancer Screening on Surgical Outcomes

NCT06416501

Prognosis Colorectal Cancer Screening

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Second Primary Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Without prior cancer

No interventions assigned to this group