Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189547
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-12-09
Brief Title:
Impact of 10 Different Prior Cancer History on Survival of Patients Who Underwent Surgery for Second Primary Colorectal Cancer a Population-based Cohort Study
Sponsor:
Guangzhou Medical University
Organization:
Guangzhou Medical University
Study Overview
Official Title:
Masters Student in Gastrointestinal Surgery at the First Affiliated Hospital of Guangzhou Medical University
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators collected data with the SEERStat software version 841 accession number 20377-Nov2021 The patients with confirmed diagnoses of CRC site code C180-209 and C260 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 patients 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 deathpatients 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 Fishers 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 02 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 005 was considered statistically significant R software version 423 was used for all statistical analysis
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 deathpatients 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 Fishers 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 02 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 005 was considered statistically significant R software version 423 was used for all statistical analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None