FRENCH STUDYNCT04224896
Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population
An observational study of FRENCH STUDY, run by Hôpital Edouard Herriot.
Trial summary
Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- FRENCH STUDY
- What is being tested?
- UPPER ENDOSCOPY
- How many people
- 335 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 31 Dec 2015
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIGH RISK OF OESOPHAGEAL SQUAMOUS CELL CARCINOMA
Who may be able to join
- Patients had a history or current SCC
Who cannot join
- NONE
About this study
Official title: Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population: a Randomised Controlled Multicentre Trial
Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and high-grade dysplasia (HGD) in current practice (including tertiary care centres, local hospitals and private clinics).
- Conditions
- FRENCH STUDY
- Being tested
- UPPER ENDOSCOPY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPPER ENDOSCOPYDiagnostic test
UPPER ENDOSCOPY
| Study group | Role | What they receive |
|---|---|---|
| NBI PATIENT | Not described Receives: Diagnostic Test: UPPER ENDOSCOPY | |
| LUGOL PATIENT | Not described Receives: Diagnostic Test: UPPER ENDOSCOPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Mar 2011
- Primary completion1 Mar 2011
- Study completion31 Dec 2015
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 FRENCH STUDYStudies 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
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Christophe Saurin, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224896
- Sponsor's protocol ID
- SFED
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gruner M, Denis A, Masliah C, Amil M, Metivier-Cesbron E, Luet D, Kaasis M, Coron E, Le Rhun M, Lecleire S, Antonietti M, Legoux JL, Lefrou L, Renkes P, Tarreirias AL, Balian P, Rey P, Prost B, Cellier C, Rahmi G, Samaha E, Fratte S, Guerrier B, Landel V, Touzet S, Ponchon T, Pioche M. Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial. Endoscopy. 2021 Jul;53(7):674-682. doi: 10.1055/a-1224-6822. Epub 2020 Oct 1.
PubMed 32698233
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population: a Randomised Controlled Multicentre Trial
- ClinicalTrials.gov ID
- NCT04224896
- Acronym / sponsor ID
- SFED
- Conditions
- FRENCH STUDY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 13 Jan 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.
Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and high-grade dysplasia (HGD) in current practice (including tertiary care centres, local hospitals and private clinics).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBI PATIENT | – | Diagnostic Test: UPPER ENDOSCOPY |
| LUGOL PATIENT | – | Diagnostic Test: UPPER ENDOSCOPY |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIGH RISK OF OESOPHAGEAL SQUAMOUS CELL CARCINOMA
Key inclusion criteria (1 listed)
- Patients had a history or current SCC
Key exclusion criteria (1 listed)
- NONE
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 |
|---|---|---|
| UPPER ENDOSCOPYUPPER ENDOSCOPY | Diagnostic test | LUGOL PATIENT, NBI PATIENT |
Primary outcome
SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES
Time frame: 4 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 13 Jan 2020.
- Derived from this study: PubMed 32698233Gruner M, Denis A, Masliah C, Amil M, Metivier-Cesbron E, Luet D, Kaasis M, Coron E, Le Rhun M, Lecleire S, Antonietti M, Legoux JL, Lefrou L, Renkes P, Tarreirias AL, Balian P, Rey P, Prost B, Cellier C, Rahmi G, Samaha E, Fratte S, Guerrier B, Landel V, Touzet S, Ponchon T, Pioche M. Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial. Endoscopy. 2021 Jul;53(7):674-682. doi: 10.1055/a-1224-6822. Epub 2020 Oct 1.
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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 FRENCH STUDY, run by Hôpital Edouard Herriot.
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 13 Jan 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?
SPECIFICITY OF THE TWO DIAGNOSTIC STRATEGIES (time frame: 4 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 NCT04224896, 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 13 Jan 2020.