Hepatitis CTROCENDONCT05103085
Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille
An observational study of Hepatitis C, run by Hôpital Européen Marseille at 1 site in France.
Trial summary
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Rapid diagnostic orientation test (TROD) for Hepatitis C
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2022to Sep 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Patients aged 50 and over hospitalized in the digestive endoscopy department
Who may be able to join
- Aged ≥ 50
- Giving free and informed written consent
- Being affiliated with or benefiting from a social security scheme
Who cannot join
- Patient unable to express consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Européen Marseille
Marseille, 13003
Myriam BENNANI, 0413428351 ext. +33, m.bennani@hopital-europeen.fr
Patrick DUKAN, Dr
About this study
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated .
French government recommendations aim to achieve elimination of hepatitis C virus HCV (as early as 2025) and since April 2018 the European Hospital Marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital.
Read more
Since 2017, direct-acting antiviral treatments have become available in France to all patients infected with HCV, regardless of the degree of severity of their disease. These treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. As of today, it is estimated that there are still 110,000 people likely to be treated in France. Among them, 75,000 are unaware of being HCV positive, people who need to be tested.
With one of the largest volumes of digestive endoscopic examinations in France, the European Hospital Marseille may be a significant source of screening for hepatitis C.
Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in the endoscopy department at the European Hospital Marseille.
- Conditions
- Hepatitis C
- Being tested
- Rapid diagnostic orientation test (TROD) for Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnostic orientation test (TROD) for Hepatitis CDiagnostic test
Inclusion of patients during the consultation with the gastroenterologist, before hospitalization in the digestive endoscopy department. Each consenting patient benefits from a HCV screening using TROD on the day of their hospitalization in the department.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patient undergoing digestive endoscopy and aged 50 years and over Receives: Diagnostic Test: Rapid diagnostic orientation test (TROD) for Hepatitis C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy.
Measured: 16 months
Secondary outcomes (3)
Number of patients who refuse viral screening
Measured: 16 months
Investigation and identification of potential risk factors in patients diagnosed positive for chronic viral hepatitis C
Measured: 16 months
Number of viremic patients without risk factor
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start24 Jan 2022
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103085
- Sponsor's protocol ID
- 21-24
- Acronym
- TROCENDO
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 10 Feb 2022
- 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 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille
- ClinicalTrials.gov ID
- NCT05103085
- Acronym / sponsor ID
- TROCENDO / 21-24
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 2 Nov 2021 (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.
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated .
French government recommendations aim to achieve elimination of hepatitis C virus HCV (as early as 2025) and since April 2018 the European Hospital Marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital.
Since 2017, direct-acting antiviral treatments have become available in France to all patients infected with HCV, regardless of the degree of severity of their disease. These treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. As of today, it is estimated that there are still 110,000 people likely to be treated in France. Among them, 75,000 are unaware of being HCV positive, people who need to be tested.
With one of the largest volumes of digestive endoscopic examinations in France, the European Hospital Marseille may be a significant source of screening for hepatitis C.
Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in the endoscopy department at the European Hospital Marseille.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Diagnostic Test: Rapid diagnostic orientation test (TROD) for Hepatitis CPatient undergoing digestive endoscopy and aged 50 years and over |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 50 and over hospitalized in the digestive endoscopy department
Key inclusion criteria (3 listed)
- Aged ≥ 50
- Giving free and informed written consent
- Being affiliated with or benefiting from a social security scheme
Key exclusion criteria (1 listed)
- Patient unable to express consent
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 |
|---|---|---|
| Rapid diagnostic orientation test (TROD) for Hepatitis CInclusion of patients during the consultation with the gastroenterologist, before hospitalization in the digestive endoscopy department. Each consenting patient benefits from a HCV screening using TROD on the day of their hospitalization in the department. | Diagnostic test | Experimental |
Primary outcome
Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy.
Time frame: 16 months
3 secondary outcomes
Number of patients who refuse viral screening
Time frame: 16 months
Investigation and identification of potential risk factors in patients diagnosed positive for chronic viral hepatitis C
Time frame: 16 months
Number of viremic patients without risk factor
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- 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.
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 Hepatitis C, run by Hôpital Européen Marseille 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 3 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: status not confirmed, as of the sponsor's last update on 10 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myriam BENNANI (0413428351 ext. +33, m.bennani@hopital-europeen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy. (time frame: 16 months). 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 Feb 2022.