Clinical trial NCT04553458: Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma
Official title: Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
HCC
Hepatoma
primary liver tumours
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes.

Brief summary: EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Detailed description: Background:

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Methods:

This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).

During the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* with hepatocellular carcinoma

Exclusion Criteria:

* severely-ill patients
* With other system comorbidities,
* presence of extrahepatic metastasis,
* patients who dropped from the follow-up list after treatment.

Primary outcomes:
measure: CURE (Number of patients cured completely from the disease)
timeFrame: one-year
measure: STABLE Disease (Number of patients with neither progression nor cure from the disease)
timeFrame: one-year
measure: PROGRESSIVE((Number of patients with progression of the disease) (measured by follow-up CT scans, increase in size, appearance of new intratumoral lesions, or appearance of new lesions
timeFrame: one-year
Secondary outcomes:
measure: DEATH (Number of patients died from the disease)
timeFrame: one-year
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Emad A. Ahmed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: