Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369480
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Brief Title:
Prognostic Factors for Survival in Patients With Cholangiocarcinoma
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Prognostic Factors for Survival in Patients With Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches Additionally we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals We anticipate that our findings could provide additional evidence for clinical decision-making improve patient outcomes and contribute to the knowledge in the field
Detailed Description:
BACKGROUND
Cholangiocarcinoma CCA is a highly aggressive neoplasia and is considered the second most common primary liver cancer 1 Its global mortality has shown an upward trend over the last two decades 2 with a survival rate of less than 5 at 5 years The poor prognosis is related to late-stage detection since CCA can be asymptomatic in its early stages 3 In Denmark the estimated cumulative risk of mortality due to CCA was 074 for men ranking 20th in all of Europe and 034 for women ranking 6th in Europe 4
CCA is anatomically classified into three groups intrahepatic perihilar and distal CCA 12 Additionally CCA can be classified as mass-forming periductal infiltrating and intraductal based on tumor location which may be associated with tumor morphology 3 A precise anatomical classification of CCA in each case is essential for accurately assessing potential complications 1
The diagnosis staging and treatment of CCA can be challenging and are typically performed by a multidisciplinary team MDT of specialists MDT meetings are a common practice in cancer care aimed at improving survival However it is important to note that there are currently no standardized recommendations for MDT practices in CCA 2 Recently authors have made efforts to identify areas of improvement and establish standard guidelines for MDT decisions based on the current practices of specialized European teams with expertise in CCA According to the recommendations of the European Network for the Study of Cholangiocarcinoma international guidelines should be utilized for MDT decisions However preference for national guidelines should be given 2 Nevertheless at the moment there are not in Denmark a national guideline to determine the most optimal treatment for CCA patients based on local statistics
Hence the objective of this retrospective study was to determine the survival rates of CCA patients based on different therapeutic approaches Additionally we aimed to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals We anticipate that our findings could provide additional evidence for clinical decision-making improve patient outcomes and contribute to the knowledge in the field
AIMS AND HYPOTHESIS
Aim I Determine the survival rates of CCA patients based on various therapeutic approaches following the MDT decision
Aim II Determine the risk factors associated with unfavorable overall survival in CCA patients
Hypothesis Advanced age male gender poor performance status non-operability lack of tumor resectability and being treated in a hospital where the MDT decision is made all pose as poor survival risk factors for CCA patients In contrast we anticipate a better prognosis for patients undergoing curative treatment surgery compared to non-surgical treatments Finally our hypothesis suggests that chemotherapy provides a better prognosis than no treatment in CCA patients
KEY DATA SOURCES
Primary data sources Patients will be identified in the Danish Liver-Biliary Cancer Database and data was retrieved retrospectively from medical records in individual centers The Danish Data Protection Agency p-2023-14848 has approved the study
Inclusion criteria Patients eligibility for this study is contingent on a diagnosis of CCA confirmed by the MDT from Aalborg Universitetshospital Aarhus Universitetshospital Odense Universitetshospital and Rigshospitalet in Denmark from 2013 to 2020
Exclusion criteria We will exclude from the analysis all records resulting from more than one intervention on the same patient Additionally all patients whose cholangiocarcinoma diagnosis was canceled following the MDT meeting were also excluded as well those with inconsistent data regarding date of reference to the MDT
DEFINITION OF PRIMARY OUTCOMES Overall survival will be defined as the period from the initial diagnosis of the disease to the registered date of death regardless of the cause The disease diagnosis will be determined from the date of MDT referral and the date of death will be based on the information provided in the Danish Civil Registration CPR number
STATISTICAL ANALYSIS Patient baseline characteristics were described using the mean and standard deviation SD for continuous data and frequency and percentage for categorical data Differences between treatment plan groups in variables with a normal distribution were analyzed with an ANOVA test Non-normally distributed data were analyzed with Kruskal-Wallis test and presented as medians and interquartile ranges Overall survival was calculated from the date of referral to the MDT to the date of death reported in the Danish Civil Registration CPR number Survival analysis was conducted using the Kaplan-Meier estimator with a 95 confidence interval The analysis of risk factors associated with CCA patients survival was performed using univariate Cox regression analysis Significance was considered when the P-value was 005 All analyses were conducted using SPSS version 290011 171
Cholangiocarcinoma CCA is a highly aggressive neoplasia and is considered the second most common primary liver cancer 1 Its global mortality has shown an upward trend over the last two decades 2 with a survival rate of less than 5 at 5 years The poor prognosis is related to late-stage detection since CCA can be asymptomatic in its early stages 3 In Denmark the estimated cumulative risk of mortality due to CCA was 074 for men ranking 20th in all of Europe and 034 for women ranking 6th in Europe 4
CCA is anatomically classified into three groups intrahepatic perihilar and distal CCA 12 Additionally CCA can be classified as mass-forming periductal infiltrating and intraductal based on tumor location which may be associated with tumor morphology 3 A precise anatomical classification of CCA in each case is essential for accurately assessing potential complications 1
The diagnosis staging and treatment of CCA can be challenging and are typically performed by a multidisciplinary team MDT of specialists MDT meetings are a common practice in cancer care aimed at improving survival However it is important to note that there are currently no standardized recommendations for MDT practices in CCA 2 Recently authors have made efforts to identify areas of improvement and establish standard guidelines for MDT decisions based on the current practices of specialized European teams with expertise in CCA According to the recommendations of the European Network for the Study of Cholangiocarcinoma international guidelines should be utilized for MDT decisions However preference for national guidelines should be given 2 Nevertheless at the moment there are not in Denmark a national guideline to determine the most optimal treatment for CCA patients based on local statistics
Hence the objective of this retrospective study was to determine the survival rates of CCA patients based on different therapeutic approaches Additionally we aimed to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals We anticipate that our findings could provide additional evidence for clinical decision-making improve patient outcomes and contribute to the knowledge in the field
AIMS AND HYPOTHESIS
Aim I Determine the survival rates of CCA patients based on various therapeutic approaches following the MDT decision
Aim II Determine the risk factors associated with unfavorable overall survival in CCA patients
Hypothesis Advanced age male gender poor performance status non-operability lack of tumor resectability and being treated in a hospital where the MDT decision is made all pose as poor survival risk factors for CCA patients In contrast we anticipate a better prognosis for patients undergoing curative treatment surgery compared to non-surgical treatments Finally our hypothesis suggests that chemotherapy provides a better prognosis than no treatment in CCA patients
KEY DATA SOURCES
Primary data sources Patients will be identified in the Danish Liver-Biliary Cancer Database and data was retrieved retrospectively from medical records in individual centers The Danish Data Protection Agency p-2023-14848 has approved the study
Inclusion criteria Patients eligibility for this study is contingent on a diagnosis of CCA confirmed by the MDT from Aalborg Universitetshospital Aarhus Universitetshospital Odense Universitetshospital and Rigshospitalet in Denmark from 2013 to 2020
Exclusion criteria We will exclude from the analysis all records resulting from more than one intervention on the same patient Additionally all patients whose cholangiocarcinoma diagnosis was canceled following the MDT meeting were also excluded as well those with inconsistent data regarding date of reference to the MDT
DEFINITION OF PRIMARY OUTCOMES Overall survival will be defined as the period from the initial diagnosis of the disease to the registered date of death regardless of the cause The disease diagnosis will be determined from the date of MDT referral and the date of death will be based on the information provided in the Danish Civil Registration CPR number
STATISTICAL ANALYSIS Patient baseline characteristics were described using the mean and standard deviation SD for continuous data and frequency and percentage for categorical data Differences between treatment plan groups in variables with a normal distribution were analyzed with an ANOVA test Non-normally distributed data were analyzed with Kruskal-Wallis test and presented as medians and interquartile ranges Overall survival was calculated from the date of referral to the MDT to the date of death reported in the Danish Civil Registration CPR number Survival analysis was conducted using the Kaplan-Meier estimator with a 95 confidence interval The analysis of risk factors associated with CCA patients survival was performed using univariate Cox regression analysis Significance was considered when the P-value was 005 All analyses were conducted using SPSS version 290011 171
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