Liver SurgeryBDD CHIRHEPNCT03686137
Institut Paoli Calmettes Hepatic Surgery Database
An observational study of Liver Surgery, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Database of patients who undergo hepatic surgery for: benign diseases, primary or secondary liver cancer at Institut Paoli-Calmettes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Surgery
- What is being tested?
- Data collection
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2017to Nov 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient treated at Institut Paoli-Calmettes who undergo liver surgery for benign liver tumor, primary or secondary liver cancer
Who may be able to join
- Patient undergoing liver surgery for benign liver tumor, primary or secondary liver cancer
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, 13009
Dominique Genre, MD, 0033491223778, drci.up@ipc.unicancer.fr
Ugo Marchese
About this study
Database of patients who undergo hepatic surgery for: benign diseases, primary or secondary liver cancer at Institut Paoli-Calmettes
- Conditions
- Liver Surgery
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Colelction of pre-operative, surgical and post-surgical data
| Study group | Role | What they receive |
|---|---|---|
| Institut Paoli-Calmettes patients undergoing liver surgery | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological description
Epidemiological description of the patients who undergo hepatic surgery at Institut Paoli-Calmettes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start6 Nov 2017
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SurgeryStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugo Marchese, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686137
- Sponsor's protocol ID
- BDD CHIRHEP-IPC 2017-003
- Acronym
- BDD CHIRHEP
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- 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 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institut Paoli Calmettes Hepatic Surgery Database
- ClinicalTrials.gov ID
- NCT03686137
- Acronym / sponsor ID
- BDD CHIRHEP / BDD CHIRHEP-IPC 2017-003
- Conditions
- Liver Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 26 Sep 2018 (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.
Database of patients who undergo hepatic surgery for: benign diseases, primary or secondary liver cancer at Institut Paoli-Calmettes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Institut Paoli-Calmettes patients undergoing liver surgery | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated at Institut Paoli-Calmettes who undergo liver surgery for benign liver tumor, primary or secondary liver cancer
Key inclusion criteria (1 listed)
- Patient undergoing liver surgery for benign liver tumor, primary or secondary liver cancer
Key exclusion criteria (1 listed)
- Patient refusal
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 |
|---|---|---|
| Data collectionColelction of pre-operative, surgical and post-surgical data | Other | Institut Paoli-Calmettes patients undergoing liver surgery |
Primary outcome
Epidemiological description
Time frame: 5 years
Epidemiological description of the patients who undergo hepatic surgery at Institut Paoli-Calmettes
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 26 Sep 2018.
- 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.
Ugo Marchese principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Surgery, run by Institut Paoli-Calmettes at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dominique Genre, MD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological description (time frame: 5 years). 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 26 Sep 2018.