- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02374697
Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis
December 8, 2015 updated by: Assistance Publique - Hôpitaux de Paris
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
470
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bièvres, France
- Centre de Pathologie- Bièvres
-
Créteil, France
- Hopital Henri Mondor
-
Eaubonne, France
- Centre Hospitalier Simone Veil
-
Le Kremlin-Bicêtre, France, 94270
- Hôpital Bicêtre
-
Paris, France, 75012
- Hopital Saint Antoine
-
Paris, France
- Hopital Bichat
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Paris, France
- Hopital Saint Louis
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Paris, France
- Hôpital Cochin
-
Pontoise, France, 95303
- Centre Hospitalier René Dubos
-
Villejuif, France
- Hôpital Paul Brousse
-
Villeneuve Saint Georges, France
- Centre Hospitalier de Villeneuve Saint Georges
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients in need for a second medical opinion on a pathological sample
Description
Inclusion Criteria:
- All patients in need for a second medical opinion on a pathological sample
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Before tele-expertise
Usual second opinion with pathological slides sent by mailing
|
|
During Tele-expertise
Second opinion with tele-expertise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay of second medical opinion
Time Frame: Up to 10 weeks
|
Between preparation of the slide and the result
|
Up to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of second medical opinion requested
Time Frame: During the whole study (around 8 months)
|
During the whole study (around 8 months)
|
|
Overall costs
Time Frame: Within 6 months after the start of tele-expertise
|
Sum of the durations of the professionals immobilization for performing a diagnosis x wages + costs of the telemedicine solution development and implementation.
|
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)
|
During the whole study (around 8 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Isabelle Durand-Zaleski, MD, PhD, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
- Principal Investigator: Catherine Guettier, MD, PhD, Hôpital Bicêtre. Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Charrier 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
February 5, 2015
First Submitted That Met QC Criteria
February 24, 2015
First Posted (Estimate)
March 2, 2015
Study Record Updates
Last Update Posted (Estimate)
December 9, 2015
Last Update Submitted That Met QC Criteria
December 8, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLM-Pathology Expertise
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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