NCT02374697

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

February 5, 2015

Last Update Submit

December 8, 2015

Conditions

Keywords

Second opinion

Outcome Measures

Primary Outcomes (1)

  • Delay of second medical opinion

    Between preparation of the slide and the result

    Up to 10 weeks

Secondary Outcomes (3)

  • Number of second medical opinion requested

    During the whole study (around 8 months)

  • Overall costs

    Within 6 months after the start of tele-expertise

  • Number of times that the pathologist who gave the second opinion required the original material

    During the whole study (around 8 months)

Study Arms (2)

Before tele-expertise

Usual second opinion with pathological slides sent by mailing

During Tele-expertise

Second opinion with tele-expertise

Device: During tele-expertise

Interventions

During Tele-expertise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in need for a second medical opinion on a pathological sample

You may qualify if:

  • All patients in need for a second medical opinion on a pathological sample

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Saint Antoine

Paris, Paris, 75012, France

Location

Centre de Pathologie- Bièvres

Bièvres, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Centre Hospitalier Simone Veil

Eaubonne, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Bichat

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Saint Louis

Paris, France

Location

Centre Hospitalier René Dubos

Pontoise, 95303, France

Location

Hôpital Paul Brousse

Villejuif, France

Location

Centre Hospitalier de Villeneuve Saint Georges

Villeneuve-Saint-Georges, France

Location

Related Publications (2)

  • 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.

    PMID: 22617736BACKGROUND
  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed tissue

MeSH Terms

Conditions

Pathological Conditions, Anatomical

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Guettier, MD, PhD

    Hôpital Bicêtre. Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Isabelle Durand-Zaleski, MD, PhD

    DRCD URC Eco. Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

March 2, 2015

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-06

Locations