Carcinoma, HpatocellularRO6-HCCNCT07265076
Role of Omega-6 Fatty Acids in Hepatocellular Carcinoma Development.
An observational study of Carcinoma, Hpatocellular, run by Sohag University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Hpatocellular
- What is being tested?
- Omega 6 fatty acid
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- History of chronic inflammatory (except for liver cirrhosis or HCC) or autoimmune diseases.
- Current use of omega-6 or omega-3 fatty acid supplements.
- Presence of other types of cancer.
- Pregnant or lactating women.
- presence of severe comorbid condition.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Carcinoma, Hpatocellular
- Being tested
- Omega 6 fatty acid
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 6 fatty acidDietary 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 .
| Study group | Role | What they receive |
|---|---|---|
| HCC Patients 50-100 | Not described | |
| 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 Receives: Dietary Supplement: Omega 6 fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HpatocellularStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Maher Sobhy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265076
- Sponsor's protocol ID
- 06-HCC-Study-2025-A
- Other IDs
- Soh-Med--25-10-6MS
- Acronym
- RO6-HCC
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Omega-6 Fatty Acids in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07265076
- Acronym / sponsor ID
- RO6-HCC / 06-HCC-Study-2025-A
- Conditions
- Carcinoma, Hpatocellular
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC Patients 50-100 | – | – |
| HCC Patients Healthy Controls | – | Dietary Supplement: Omega 6 fatty acidHCC 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- History of chronic inflammatory (except for liver cirrhosis or HCC) or autoimmune diseases.
- Current use of omega-6 or omega-3 fatty acid supplements.
- Presence of other types of cancer.
- Pregnant or lactating women.
- presence of severe comorbid condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 6 fatty acidParticipants 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 . | Dietary supplement | HCC Patients Healthy Controls |
Primary outcome
Serum Omega-6 Fatty Acid Levels
Time frame: At baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- General scientific background on hepatocellular carcinoma and related liver diseasesLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hpatocellular, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mariam maher, Resident doctor (+201220821335, mahermariam971@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Omega-6 Fatty Acid Levels (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.