Anatomical Pathological ConditionNCT02374697
Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis
An observational study of Anatomical Pathological Condition, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
Trial summary
The purpose of this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anatomical Pathological Condition
- What is being tested?
- During tele-expertise
- Type of treatment
- Medical device
- How many people
- 470 participants
- Where
- 11 sitesFrance
- Study dates
- Sep 2013to Oct 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 in need for a second medical opinion on a pathological sample
Who may be able to join
- All patients in need for a second medical opinion on a pathological sample
Who cannot join
- None
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre de Pathologie- Bièvres
Bièvres
Hôpital Henri Mondor
Créteil
Centre Hospitalier Simone Veil
Eaubonne
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Saint Antoine
Paris, Paris, 75012
Hôpital Bichat
Paris
Hôpital Cochin
Paris
Hôpital Saint Louis
Paris
Centre Hospitalier René Dubos
Pontoise, 95303
Hôpital Paul Brousse
Villejuif
Centre Hospitalier de Villeneuve Saint Georges
Villeneuve-Saint-Georges
About this study
The purpose of this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis.
- Conditions
- Anatomical Pathological Condition
- Being tested
- During tele-expertise
- Keywords
- Second opinion
- Medical subject headings
- Pathological Conditions, Anatomical
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 |
|---|---|---|
| Before tele-expertise | Usual second opinion with pathological slides sent by mailing | |
| During Tele-expertise | Second opinion with tele-expertise Receives: Device: During tele-expertise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay of second medical opinion
Between preparation of the slide and the result
Measured: Up to 10 weeks
Secondary outcomes (3)
Number of second medical opinion requested
Measured: During the whole study (around 8 months)
Overall costs
Sum of the durations of the professionals immobilization for performing a diagnosis x wages + costs of the telemedicine solution development and implementation.
Measured: Within 6 months after the start of tele-expertise
Number of times that the pathologist who gave the second opinion required the original material
Measured: During the whole study (around 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anatomical Pathological ConditionStudies 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
- 470 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
- NCT02374697
- Sponsor's protocol ID
- TLM-Pathology Expertise
- Status last verified
- Jun 2015
- First submitted
- 5 Feb 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
PubMed 22617736Charrier 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
- Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis
- ClinicalTrials.gov ID
- NCT02374697
- Acronym / sponsor ID
- TLM-Pathology Expertise
- Conditions
- Anatomical Pathological Condition
- Keywords
- Second opinion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Mar 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 this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before tele-expertise | – | –Usual second opinion with pathological slides sent by mailing |
| During Tele-expertise | – | Device: During tele-expertiseSecond opinion with tele-expertise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in need for a second medical opinion on a pathological sample
Key inclusion criteria (1 listed)
- All patients in need for a second medical opinion on a pathological sample
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
Delay of second medical opinion
Time frame: Up to 10 weeks
Between preparation of the slide and the result
3 secondary outcomes
Number of second medical opinion requested
Time frame: During the whole study (around 8 months)
Overall costs
Time frame: Within 6 months after the start of tele-expertise
Number of times that the pathologist who gave the second opinion required the original material
Time frame: During the whole study (around 8 months)
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 22617736Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
- 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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomical Pathological Condition, run by Assistance Publique - Hôpitaux de Paris at 11 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 11 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?
Delay of second medical opinion (time frame: Up to 10 weeks). 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 NCT02374697, which also lists 2 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.