Hepatocellular CarcinomaNCT06505291
Long-term Management of Patients With Ruptured HCC
An observational study of Hepatocellular Carcinoma, run by University Hospital, Caen.
Trial summary
The main objective of this work is to evaluate the prevalence and results of specific management of HCC after spontaneous rupture, since the arrival of sorafenib in 2008. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 30 Apr 2024
- How long will I take part?
- 16 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with ruptured hepatocellular carcinoma
Who may be able to join
- Ruptured hepatocellular carcinoma with or without cirrhosis
Who cannot join
- Liver adenoma without histologically proven HCC
- Other benign or malignant liver tumors
- ATCD of potentially triggering interventional procedure in the previous month.
- Hemorrhagic ascites without tumor
- Intratumoral hemorrhages without hemoperitoneum or capsular rupture
About this study
The main objective of this work is to evaluate the prevalence and results of specific management of HCC after spontaneous rupture, since the arrival of sorafenib in 2008.
Read the detailed description
Retrospective, observational, multicenter study over the period from January 2008 to April 2024.
Cases had to be 18 years or older. They were identified by two different methodologies adapted to the 4 participating centers. In particular, a request for ICD10 C22.0 (CHC) codes associated with K66.1 (hemoperitoneum) was carried out by the medical information departments (DIM) of the Caen University Hospital and the Avicenne hospital. Secondly, the automated keyword selection tools "Cohort 360" and "i2b2" were used at the La Pitié Salpetrière and Paul Brousse hospital centers to identify the terms "CHC" and "ruptured" in the computerized patient files. Secondarily, duplicates and coding errors were excluded.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after rupture of hepatocellular carcinoma
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jan 2008
- Primary completion1 Sep 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 only
- Time perspective
- Other
- Enrolment
- 112 participants (actual)
- Target duration
- 16 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505291
- Sponsor's protocol ID
- CHCrompu
- Status last verified
- Apr 2024
- First submitted
- 25 Jun 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Commin A, Metivier C, Allaire M, Lubrano J, Claudinot A, Coilly A, Allard MA, Roux C, Scatton O, Nault JC, Sutter O, Ganne-Carrie N, Ngo TV, Goff VL, Ali ZB, Tedlaouti H, Papin J, Habireche M, Lebedel L, Perignon C, Dao T, Morello R, Ollivier-Hourmand I. Early Hemostatic Treatment Could Improve 30-Day Survival After Spontaneous Rupture of Hepatocellular Carcinoma. Liver Int. 2025 Oct;45(10):e70332. doi: 10.1111/liv.70332.
PubMed 40990229
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Management of Patients With Ruptured HCC
- ClinicalTrials.gov ID
- NCT06505291
- Acronym / sponsor ID
- CHCrompu
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 17 Jul 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 main objective of this work is to evaluate the prevalence and results of specific management of HCC after spontaneous rupture, since the arrival of sorafenib in 2008.
Detailed description
Retrospective, observational, multicenter study over the period from January 2008 to April 2024.
Cases had to be 18 years or older. They were identified by two different methodologies adapted to the 4 participating centers. In particular, a request for ICD10 C22.0 (CHC) codes associated with K66.1 (hemoperitoneum) was carried out by the medical information departments (DIM) of the Caen University Hospital and the Avicenne hospital. Secondly, the automated keyword selection tools "Cohort 360" and "i2b2" were used at the La Pitié Salpetrière and Paul Brousse hospital centers to identify the terms "CHC" and "ruptured" in the computerized patient files. Secondarily, duplicates and coding errors were excluded.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 16 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ruptured hepatocellular carcinoma
Key inclusion criteria (1 listed)
- Ruptured hepatocellular carcinoma with or without cirrhosis
Key exclusion criteria (5 listed)
- Liver adenoma without histologically proven HCC
- Other benign or malignant liver tumors
- ATCD of potentially triggering interventional procedure in the previous month.
- Hemorrhagic ascites without tumor
- Intratumoral hemorrhages without hemoperitoneum or capsular rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival after rupture of hepatocellular carcinoma
Time frame: 15 years
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 17 Jul 2024.
- Derived from this study: PubMed 40990229Commin A, Metivier C, Allaire M, Lubrano J, Claudinot A, Coilly A, Allard MA, Roux C, Scatton O, Nault JC, Sutter O, Ganne-Carrie N, Ngo TV, Goff VL, Ali ZB, Tedlaouti H, Papin J, Habireche M, Lebedel L, Perignon C, Dao T, Morello R, Ollivier-Hourmand I. Early Hemostatic Treatment Could Improve 30-Day Survival After Spontaneous Rupture of Hepatocellular Carcinoma. Liver Int. 2025 Oct;45(10):e70332. doi: 10.1111/liv.70332.
- 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, run by University Hospital, Caen.
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 5 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 17 Jul 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?
Survival after rupture of hepatocellular carcinoma (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505291, which also lists 1 linked publication.
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 17 Jul 2024.