Frozen SectionsTélé-extempoNCT02368769
Assessment of Tele-expertise for Frozen Section Diagnosis
An observational study of Frozen Sections, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
Trial summary
The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frozen Sections
- What is being tested?
- During Tele-expertise
- Type of treatment
- Medical device
- How many people
- 253 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2013to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who need a frozen section diagnosis
Who may be able to join
- All patients
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Service d'Anatomie pathologique. Hôpital Antoine Béclère
Clamart, 92140
Service d'anatomie pathologique. Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Service d'anatomie pathologique. Hôpital de Raincy-Montfermeil
Montfermeil, 93370
Service d'ORL. Hôpital du Raincy-Montfermeil
Montfermeil, 93370
Service d'anatomie pathologique. Hôpital Saint Antoine
Paris, 75012
Service de chirurgie viscérale. Hôpital des Diaconnesses
Paris, 75012
About this study
Official title: Multidimensional Assessment of Tele-expertise for Frozen Section Diagnosis
The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.
- Conditions
- Frozen Sections
- Being tested
- During Tele-expertise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
During Tele-expertiseDevice
| Study group | Role | What they receive |
|---|---|---|
| During tele-expertise | Remote site interpretation of frozen section Receives: Device: During Tele-expertise | |
| Before tele-expertise | Usual (on site) frozen section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon
Measured: 30 minutes after the sample extraction
Secondary outcomes (3)
Delay between extraction of the sample and the diagnosis given to the surgeon
Measured: 24h after procedure
Number of frozen section diagnosis among surgical procedures in need of frozen section diagnosis
Measured: Once a month
Overall cost of a frozen section diagnosis
Sum of the durations of the professionals immobilization for performing a diagnosis x wages + costs of the telemedicine solution development and implementation.
Measured: 6 months after the first patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frozen SectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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-control
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Catherine Guettier, MD, PhD, Principal investigator, Hôpital Bicêtre. Assistance Publique - Hôpitaux de ParisIsabelle Durand-Zaleski, MD, PhD, Principal investigator, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368769
- Sponsor's protocol ID
- TLM-Pathology Frozen Section
- Acronym
- Télé-extempo
- Status last verified
- Dec 2015
- First submitted
- 5 Feb 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gould PV, Saikali S. A comparison of digitized frozen section and smear preparations for intraoperative neurotelepathology. Anal Cell Pathol (Amst). 2012;35(2):85-91. doi: 10.3233/ACP-2011-0026.
PubMed 22297471Tetu B, Fortin JP, Gagnon MP, Louahlia S. The challenges of implementing a "patient-oriented" telepathology network; the Eastern Quebec telepathology project experience. Anal Cell Pathol (Amst). 2012;35(1):11-8. doi: 10.3233/ACP-2011-0023.
PubMed 22233700Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
PubMed 26857558
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of Tele-expertise for Frozen Section Diagnosis
- ClinicalTrials.gov ID
- NCT02368769
- Acronym / sponsor ID
- Télé-extempo / TLM-Pathology Frozen Section
- Conditions
- Frozen Sections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Feb 2015 (estimated)
- 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 purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| During tele-expertise | – | Device: During Tele-expertiseRemote site interpretation of frozen section |
| Before tele-expertise | – | –Usual (on site) frozen section |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who need a frozen section diagnosis
Key inclusion criteria (1 listed)
- All patients
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 |
|---|---|---|
| During Tele-expertise | Device | During tele-expertise |
Primary outcome
Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon
Time frame: 30 minutes after the sample extraction
3 secondary outcomes
Delay between extraction of the sample and the diagnosis given to the surgeon
Time frame: 24h after procedure
Number of frozen section diagnosis among surgical procedures in need of frozen section diagnosis
Time frame: Once a month
Overall cost of a frozen section diagnosis
Time frame: 6 months after the first patient enrollment
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 9 Dec 2015.
- Background: PubMed 22297471Gould PV, Saikali S. A comparison of digitized frozen section and smear preparations for intraoperative neurotelepathology. Anal Cell Pathol (Amst). 2012;35(2):85-91. doi: 10.3233/ACP-2011-0026.
- Background: PubMed 22233700Tetu B, Fortin JP, Gagnon MP, Louahlia S. The challenges of implementing a "patient-oriented" telepathology network; the Eastern Quebec telepathology project experience. Anal Cell Pathol (Amst). 2012;35(1):11-8. doi: 10.3233/ACP-2011-0023.
- Derived from this study: PubMed 26857558Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
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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.
Catherine Guettier, MD, PhD principal investigator
Hôpital Bicêtre. Assistance Publique - Hôpitaux de Paris
Isabelle Durand-Zaleski, MD, PhD principal investigator
DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frozen Sections, run by Assistance Publique - Hôpitaux de Paris at 6 sites 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: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon (time frame: 30 minutes after the sample extraction). 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 NCT02368769, which also lists 3 linked publications.
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 9 Dec 2015.