Hepatocellular CarcinomaNCT06409507
Research and Application for New Clinical Diagnosis and Treatment System for HBV Related HCC Liver Transplantation
An observational study of Hepatocellular Carcinoma and Liver Transplantation, run by First People's Hospital of Hangzhou.
Trial summary
The study evaluated the protein expression levels of FK506-binding protein 12 (FKBP12) in hepatocellular carcinoma (HCC) and paracancerous tissues using immunohistochemistry (IHC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplantation, Prognosis
- What is being tested?
- FKBP12 expression
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Aug 2023
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Deceased donor LT surgery was performed in all recipients at our center between January 1, 2015 and January 1, 2021. China Liver Transplant Registry database (http://www.cltr.org) was used to obtain clinical information about patients, which included age, gender, pathological characteristics, pre-LT alpha-fetoprotein (AFP), loco-regional therapy (including transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA)) before LT, model for end-stage liver disease (MELD) score, Child-Pugh score, hepatitis B virus status, sirolimus administration, date of surgery, recurrence, last follow up, and death. LT recipients were required for a follow-up examination every 3 months.
Who may be able to join
- (1) pathologically confirmed HCC (2) full post-LT follow-up record
Who cannot join
- (1)sirolimus treatment less than 30 days or after tumor recurrence (2)died within 90 days (3)underwent multiple-organ transplantation
About this study
Official title: The Impact of FKBP12 on the Prognosis and Sirolimus Administration in Liver Transplantation Recipients With Hepatocellular Carcinoma: A Single-center Retrospective Cohort Study
The study evaluated the protein expression levels of FK506-binding protein 12 (FKBP12) in hepatocellular carcinoma (HCC) and paracancerous tissues using immunohistochemistry (IHC). This study aimed to determine the role of FKBP12 in the outcome of liver transplantation recipients with HCC, especially those exceeding the Milan criteria. In addition, we explored how sirolimus administration affected LT recipients'prognosis depending on different FKBP12 expression, aiming to provide some advice for clinical sirolimus application after LT.
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation, Prognosis
- Being tested
- FKBP12 expression
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FKBP12 expressionGenetic
Also called sirolimus
The expressions of FKBP12 were determined by immunohistochemistry (IHC) , and the immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (0-7) represented low expression levels, and IRS (8-12) represented high expression levels.
| Study group | Role | What they receive |
|---|---|---|
| high FKBP12 expression | The immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (8-12) represented high expression levels. Receives: Genetic: FKBP12 expression | |
| low FKBP12 expression | The immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (0-7) represented low expression levels. Receives: Genetic: FKBP12 expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the length of months between surgery and the last follow-up or death
Measured: 2015.1.1-2021.1.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jan 2015
- Primary completion1 Jan 2021
- Study completion1 Aug 2023
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.
- 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409507
- Sponsor's protocol ID
- 2018768
- Status last verified
- Mar 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of FKBP12 on the Prognosis and Sirolimus Administration in Liver Transplantation Recipients With Hepatocellular Carcinoma: A Single-center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06409507
- Acronym / sponsor ID
- 2018768
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 10 May 2024 (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.
The study evaluated the protein expression levels of FK506-binding protein 12 (FKBP12) in hepatocellular carcinoma (HCC) and paracancerous tissues using immunohistochemistry (IHC). This study aimed to determine the role of FKBP12 in the outcome of liver transplantation recipients with HCC, especially those exceeding the Milan criteria. In addition, we explored how sirolimus administration affected LT recipients'prognosis depending on different FKBP12 expression, aiming to provide some advice for clinical sirolimus application after LT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high FKBP12 expression | – | Genetic: FKBP12 expressionThe immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (8-12) represented high expression levels. |
| low FKBP12 expression | – | Genetic: FKBP12 expressionThe immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (0-7) represented low expression levels. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Deceased donor LT surgery was performed in all recipients at our center between January 1, 2015 and January 1, 2021. China Liver Transplant Registry database (http://www.cltr.org) was used to obtain clinical information about patients, which included age, gender, pathological characteristics, pre-LT alpha-fetoprotein (AFP), loco-regional therapy (including transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA)) before LT, model for end-stage liver disease (MELD) score, Child-Pugh score, hepatitis B virus status, sirolimus administration, date of surgery, recurrence, last follow up, and death. LT recipients were required for a follow-up examination every 3 months.
Key inclusion criteria (1 listed)
- (1) pathologically confirmed HCC (2) full post-LT follow-up record
Key exclusion criteria (1 listed)
- (1)sirolimus treatment less than 30 days or after tumor recurrence (2)died within 90 days (3)underwent multiple-organ transplantation
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 |
|---|---|---|
| FKBP12 expressionAlso: sirolimusThe expressions of FKBP12 were determined by immunohistochemistry (IHC) , and the immunoreactive score (IRS), calculated by multiplying the staining intensity grades by the proportion of positive cells, was used to assess the expression levels of FKBP12. IRS (0-7) represented low expression levels, and IRS (8-12) represented high expression levels. | Genetic | high FKBP12 expression, low FKBP12 expression |
Primary outcome
Overall survival
Time frame: 2015.1.1-2021.1.1
the length of months between surgery and the last follow-up or death
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 10 May 2024.
- Individual participant dataSharing planned: No
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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 Transplantation, run by First People's Hospital of Hangzhou.
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 1 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 10 May 2024. 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 survival (time frame: 2015.1.1-2021.1.1). 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 10 May 2024.