Role of Omega-6 Fatty Acids in Hepatocellular Carcinoma Development.

NCT ID: NCT07265076

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-10-01

Brief Summary

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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 .

Detailed Description

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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 .

Conditions

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Carcinoma, Hpatocellular

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HCC Patients 50-100

No interventions assigned to this group

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

Omega 6 fatty acid

Intervention Type DIETARY_SUPPLEMENT

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 .

Interventions

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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 .

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Maher Sobhy

Resident Doctor of Tropical Medicine and Gastro-enterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mariam maher, Resident doctor

Role: CONTACT

+201220821335

Related Links

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https://pubmed.ncbi.nlm.nih.gov/

General scientific background on hepatocellular carcinoma and related liver diseases

Other Identifiers

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Soh-Med--25-10-6MS

Identifier Type: REGISTRY

Identifier Source: secondary_id

06-HCC-Study-2025-A

Identifier Type: -

Identifier Source: org_study_id

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