Hepatocellular CarcinomaNCT04412161
Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP
An observational study of Hepatocellular Carcinoma and Liver Transplant Disorder, run by Inonu University.
Trial summary
Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with >6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP <200 ng/ml and GGT <104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplant Disorder
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2006to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma
Who may be able to join
- Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma
Who cannot join
- Early postoperative mortality (within 90 days)
- Advanced stage tumors (explant patology revealed that tumor continues in the surgical cite such as positive lymph node metastases, macroscopic portal vein trombosis, diaphragmatic invasion, etc)
About this study
Official title: Retrospective Cohort Study-Analysis of LT Patients With HCC (Maximum Tumor Diameter > 6 cm).
Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with >6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP <200 ng/ml and GGT <104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.
Read the detailed description
Background:A retrospective analysis was performed of prospectively-collected transplant data on outcomes of patients with large size HCCs,to examine possible prognostically-useful factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were identified. Their survival and full clinical characteristics were examined, with respect to serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT 104 IU/ml were identified and used in this study. Significantly longer overall-survival and disease-free-survival were found for patients who had lower values of either parameter, compared with higher values.Even greater differences in survival were found when the 2 parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most consistent clinical correlates for these longer survivals were degree of tumor differentiation and absence of microscopic portal venous invasion.Two tumor size bands were identified,to search for the limits of this approach with larger tumors, namely 6-10 and >10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic identifier for patients with large size HCCs being treated by liver transplantation.
- Being tested
- Liver transplantation
- Keywords
- Hepatic malignancy, GGT, living donor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Living donor liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Extra-Malatya | Liver transplant patients with MTD>6 cm of HCC Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall and disease free survivals
to analyse the factors that effect the survivals
Measured: five years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start19 Apr 2006
- Primary completion1 Jan 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Ince, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412161
- Sponsor's protocol ID
- GGT-HCC-6CM
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study-Analysis of LT Patients With HCC (Maximum Tumor Diameter > 6 cm).
- ClinicalTrials.gov ID
- NCT04412161
- Acronym / sponsor ID
- GGT-HCC-6CM
- Keywords
- Hepatic malignancy, GGT, living donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 19 Apr 2006 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Jun 2020 (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.
Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with >6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP <200 ng/ml and GGT <104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.
Detailed description
Background:A retrospective analysis was performed of prospectively-collected transplant data on outcomes of patients with large size HCCs,to examine possible prognostically-useful factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were identified. Their survival and full clinical characteristics were examined, with respect to serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT 104 IU/ml were identified and used in this study. Significantly longer overall-survival and disease-free-survival were found for patients who had lower values of either parameter, compared with higher values.Even greater differences in survival were found when the 2 parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most consistent clinical correlates for these longer survivals were degree of tumor differentiation and absence of microscopic portal venous invasion.Two tumor size bands were identified,to search for the limits of this approach with larger tumors, namely 6-10 and >10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic identifier for patients with large size HCCs being treated by liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extra-Malatya | – | Procedure: Liver transplantationLiver transplant patients with MTD>6 cm of HCC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma
Key inclusion criteria (1 listed)
- Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma
Key exclusion criteria (2 listed)
- Early postoperative mortality (within 90 days)
- Advanced stage tumors (explant patology revealed that tumor continues in the surgical cite such as positive lymph node metastases, macroscopic portal vein trombosis, diaphragmatic invasion, etc)
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 |
|---|---|---|
| Liver transplantationLiving donor liver transplantation | Procedure or surgery | Extra-Malatya |
Primary outcome
overall and disease free survivals
Time frame: five years follow up
to analyse the factors that effect the survivals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Transplant Disorder, run by Inonu 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall and disease free survivals (time frame: five years follow up). 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 2 Jun 2020.