Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628661
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Ten-Year Outcomes of Operable Solitary Hepatocellular Carcinoma Patients Impact of Tumor Size Over 65 cm and Microvascular Invasion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ten-Year Outcomes of Operable Solitary Hepatocellular Carcinoma Patients Impact of Tumor Size Over 65 cm and Microvascular Invasion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to evaualte the impact of tumor size and microvascular invasion among patients with solitary hepatocellualr carcinoma and post operation The main questions it aims to answer are
Does the tumor size have more impact on the survival and recurrence than microvascular invasion among solitary operable hepatocellular carcinoma patients
Researchers will retrospectively analyze the prospectively collected clinical database during January 2022 and December 2019 to see whether tumor size more than 65 cm or microvascular invasion
The solitary operable hepatocellular carcinoma patients would be classified based on the status of microvascular invasion and tumor size and the outcome would be evaluated among different sub-populations of the feasible subjects
Does the tumor size have more impact on the survival and recurrence than microvascular invasion among solitary operable hepatocellular carcinoma patients
Researchers will retrospectively analyze the prospectively collected clinical database during January 2022 and December 2019 to see whether tumor size more than 65 cm or microvascular invasion
The solitary operable hepatocellular carcinoma patients would be classified based on the status of microvascular invasion and tumor size and the outcome would be evaluated among different sub-populations of the feasible subjects
Detailed Description:
Data source The study utilized the Chang Gung Research Database CGRD an extensive repository of electronic medical records maintained by Chang Gung Memorial Hospital CGMH across multiple medical centers and hospitals in Taiwan Established for administrative and insurance purposes the CGRD includes comprehensive data on patient demographics diagnoses treatments and outcomes It covers a significant portion of Taiwans medical services with detailed records on outpatient emergency and inpatient visits Notably the CGRD also includes a cancer registry with thorough documentation of diagnoses staging treatment modalities recurrence and mortality data All data in cancer registry database were curated manually and make this information highly reliable1 Diagnoses are coded using the International Classification of Diseases 9th Revision Clinical Modification ICD-9-CM before 2016 and International Classification of Diseases 10th Revision Clinical Modification ICD-10-CM thereafter with all cancer registry entries manually verified for accuracy This makes the CGRD an invaluable resource for clinical research The CGRD39s extensive coverage of Taiwan39s medical landscape including a significant proportion of both inpatient and outpatient services 20 of all cancer patients data and about 34 outpatient information in Taiwan underscores its utility as an excellent data source for robust clinical research Previous studies have elaborated on the CGRDs structure and content reinforcing its role as a key resource for healthcare studies
Study design and population The study initially included all incident HCC patients from January 2002 to December 2018 by using ICD-9-CM codes 155 and ICD-10-CM codes C22 To ensure the population to be analyzed several exclusion criteria were applied Patients who did not receive any treatment after diagnosis were excluded to avoid confounding survival outcomes Age was another critical factor patients younger than 18 or older than 80 years were excluded to eliminate potential age-related biases in survival analysis Additionally patients with missing tumor size were excluded as tumor size is a crucial variable in assessing prognosis and treatment decisions Errors in survival or recurrence status or date were also excluded to maintain data integrity Lastly patients deemed non-operable were excluded to focus on those who could potentially benefit from surgical intervention Furthermore patients who did not fall into the pT1N0M0 or pT2N0M0 staging categories were excluded to ensure only early-stage patients were enrolled The remaining patients were then divided into two groups based on their stage in which subjects would be separated by TNM staging pT1N0M0 solitary HCC and pT2N0M0 solitary HCC with mVi or multiple HCCs with none size lt 5 cm Within the pT1N0M0 group patients who died within 30 days post-surgery were excluded to avoid perioperative mortality bias Additionally patients with a tumor size of 2cm were excluded to focus on more clinically significant tumors Two subgroups subjects with tumor size gt 2cm and 65cm and gt 65cm were further obtained according to our previous report that 65 cm would be the cut-off value of pT1 subjects with different prognosis For the pT2N0M0 group similar exclusions were made for patients who died within 30 days post-surgery and for errors in the Child score This group was further categorized into solitary tumor with microvascular invasion mVI and multiple tumors with none smaller than 5cm Also tumor size 65 cm was used to classify subjects with solitary tumor with mVi The outcomes were compared among different groups of enrolled subjects to realize the associations between operation outcomes and HCC with mVi and tumor size over or below 65 cm among solitary HCC patients This study approved by the Institutional Review Board of the Chang Gung Medical Foundation leverages the CGRDs rich data repository to conduct a retrospective cohort analysis IRB No 202300142B0
Study design and population The study initially included all incident HCC patients from January 2002 to December 2018 by using ICD-9-CM codes 155 and ICD-10-CM codes C22 To ensure the population to be analyzed several exclusion criteria were applied Patients who did not receive any treatment after diagnosis were excluded to avoid confounding survival outcomes Age was another critical factor patients younger than 18 or older than 80 years were excluded to eliminate potential age-related biases in survival analysis Additionally patients with missing tumor size were excluded as tumor size is a crucial variable in assessing prognosis and treatment decisions Errors in survival or recurrence status or date were also excluded to maintain data integrity Lastly patients deemed non-operable were excluded to focus on those who could potentially benefit from surgical intervention Furthermore patients who did not fall into the pT1N0M0 or pT2N0M0 staging categories were excluded to ensure only early-stage patients were enrolled The remaining patients were then divided into two groups based on their stage in which subjects would be separated by TNM staging pT1N0M0 solitary HCC and pT2N0M0 solitary HCC with mVi or multiple HCCs with none size lt 5 cm Within the pT1N0M0 group patients who died within 30 days post-surgery were excluded to avoid perioperative mortality bias Additionally patients with a tumor size of 2cm were excluded to focus on more clinically significant tumors Two subgroups subjects with tumor size gt 2cm and 65cm and gt 65cm were further obtained according to our previous report that 65 cm would be the cut-off value of pT1 subjects with different prognosis For the pT2N0M0 group similar exclusions were made for patients who died within 30 days post-surgery and for errors in the Child score This group was further categorized into solitary tumor with microvascular invasion mVI and multiple tumors with none smaller than 5cm Also tumor size 65 cm was used to classify subjects with solitary tumor with mVi The outcomes were compared among different groups of enrolled subjects to realize the associations between operation outcomes and HCC with mVi and tumor size over or below 65 cm among solitary HCC patients This study approved by the Institutional Review Board of the Chang Gung Medical Foundation leverages the CGRDs rich data repository to conduct a retrospective cohort analysis IRB No 202300142B0
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None