Clinical trial NCT06629857: A Cross Sectional Study Evaluating the Mean Levels of Alpha Fetoprotein in Patients of Hepatocellular Carcinoma and Its Correlates in Pakistan
Official title: Clinical Correlation of Alpha-Fetoprotein in Hepatocellular Carcinoma: a Cross-Sectional Study from Southeast Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma (HCC)
Alpha-fetoprotein (AFP) levels
Liver cancer biomarkers
Tumor size and AFP correlation
Hepatitis B and C in liver cancer
Non-alcoholic steatohepatitis (NASH)
AFP as a diagnostic tool
Liver tumor progression markers
Lead sponsor: Darul Sehat Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 94
Sex: ALL
Minimum age (years): 27
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of a total of 94 adult patients diagnosed with hepatocellular carcinoma (HCC) who are receiving care at Dar ul Sehat Hospital, Karachi, Pakistan. Participants will be recruited from outpatient, emergency, and inpatient departments. Eligible individuals will be aged between 27 to 80 years and must have been diagnosed with HCC within the last three months, confirmed by relevant investigations. The study aims to reflect a diverse population that includes various tumor sizes and underlying liver disease etiologies, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis, and cirrhosis. Patients will be excluded if they have elevated alpha-fetoprotein levels due to tumors other than HCC or have secondary liver metastases from other primary sites. This approach ensures that the findings are specific to HCC and its correlates, aiding in the assessment of AFP levels in this population.

Brief summary: This study aims to explore the levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (HCC). The goal is to determine whether AFP levels vary based on the size of the liver tumor or other health conditions like hepatitis B, hepatitis C, and obesity. By analyzing data from 94 patients, the study seeks to identify factors that influence AFP levels, which may help in understanding liver cancer progression and improving diagnosis and treatment approaches.


Eligibility criteria: Inclusion Criteria:

* Aged between 27 to 80 years.
* Diagnosed with hepatocellular carcinoma (HCC) within the last three months.
* Diagnosis confirmed by relevant investigations (e.g., imaging, liver biopsy).
* Able to provide informed consent.

Exclusion Criteria:

* Elevated alpha-fetoprotein levels due to tumors other than HCC.
* Presence of secondary liver metastases from other primary sites.
* Any significant comorbid conditions that could interfere with study assessments.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Mean Alpha-Fetoprotein (AFP) Levels in HCC Patients
timeFrame: Baseline measurement at time of diagnosis.
Secondary outcomes:
measure: Correlation Between AFP Levels and Tumor Size
timeFrame: At baseline (upon diagnosis).
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Darul Sehat Hospital
state: Sindh
Study officials:
References: