Role of Omega-6 Fatty Acids in Hepatocellular Carcinoma Development. (RO6-HCC)

Study of Omega-6 Fatty Acids in Patients With Hepatocellular Carcinoma

This observational study investigates the association between serum Omega-6 fatty acids and hepatocellular carcinoma development. Adult HCC patients and age - and gender matched healthy controls will be included. Serum Omega-6 levels will be compared between groups to explore potential correlations with disease presence and severity .

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Hpatocellular
• Intervention / Treatment: Dietary supplement: Omega 6 fatty acid

Detailed Description

Hepatocellular carcinoma is a leading cause of cancer related deaths worldwide . Omega-6 fatty acids have been suggested to influence liver cancer development .This observational study aims to assess the association between serum Omega-6 fatty acid levels and HCC development .

Adult patients diagnosed with HCC will be recruited from Sohag University Hospital, along with age and gender matched healthy controls . Blood samples will be collected to measure serum Omega-6 levels using standardized bio-chemical assays . clinical and laboratory data , including liver function tests and tumor stage , will also be recorded.

The study will compare Omega-6 levels between HCC patients and controls , and analyze potential correlation with disease severity .Findings may provide insights into the role of Omega-6 fatty acids in HCC pathogenesis and help identify biomarkers for early detection and risk assessment .

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: mariam maher, Resident doctor; Phone Number: +201220821335; Email: mahermariam971@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult participants aged 18 years and older will be recruited. The study will include two groups: 1) patients diagnosed with hepatocellular carcinoma confirmed by imaging or histology, and 2) age- and gender-matched healthy controls with no history of liver disease unrelated to HCC, pregnant women, or those currently taking omega fatty acid supplements will be excluded. All participants will provide informed consent prior to enrollment.

Description

Inclusion Criteria:

• 1. Adults aged 18 years and above. 2. Patients with hepatocellular carcinoma (confirmed clinically, laboratory, radiologically, or histopathologically).

  3. Ability and willingness to provide informed written consent. 4. For healthy controls: individuals without liver disease or history of malignancy, matched by age and gender.

  5. For cirrhotic controls: patients with liver cirrhosis without evidence of any malignancy, matched by age and gender.

Exclusion Criteria:

1. History of chronic inflammatory (except for liver cirrhosis or HCC) or autoimmune diseases.
2. Current use of omega-6 or omega-3 fatty acid supplements.
3. Presence of other types of cancer.
4. Pregnant or lactating women.

5. presence of severe comorbid condition.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HCC Patients 50-100
HCC Patients Healthy Controls; HCC Patients: adult patients diagnosed with Hepatocellular carcinoma , meeting inclusion/exclusion criteria healthy controls: age and gender matched healthy adults with no history of liver disease	Dietary supplement: Omega 6 fatty acid; Participants will receive an oral Omega-6 fatty acid dietary supplement in capsule form. The supplement will be administered once daily with meals for a total duration of 8 weeks. Each capsule contains a standardized dose of omega -6 fatty acids, and participants will be instructed to maintain their usual diet during the study period . compliance will be monitored though follow up visits and capsule count . no additional supplements containing omega fatty acids will be allowed during the intervention period .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Omega-6 Fatty Acid Levels	Measurement of circulating levels of Omega-6 fatty acids in blood samples of hepatocellular carcinoma patients and healthy controls using standardized laboratory techniques. The primary outcome will assess the association between serum Omega-6 concentrations and the presence of hepatocellular carcinoma.	At baseline

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

Helpful Links

• General scientific background on hepatocellular carcinoma and related liver diseases

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Fatty Acids; Lipids; Fatty Acids, Unsaturated; Fatty Acids, Omega-6
• Other Study ID Numbers: 06-HCC-Study-2025-A; Soh-Med--25-10-6MS (Registry Identifier: Medical Research Ethics Committee Faculty of Medicine - Sohag University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No