Brief 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

253

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach

1 country

6 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

2.3 years study duration

Study Start

First participant enrolled

January 1, 2013

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed

18 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

February 5, 2015

Last Update Submit

December 8, 2015

Conditions

Frozen Sections

Outcome Measures

Primary Outcomes (1)

Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon
30 minutes after the sample extraction

Secondary Outcomes (3)

Delay between extraction of the sample and the diagnosis given to the surgeon
24h after procedure
Number of frozen section diagnosis among surgical procedures in need of frozen section diagnosis
Once a month
Overall cost of a frozen section diagnosis
6 months after the first patient enrollment

Study Arms (2)

During tele-expertise

Remote site interpretation of frozen section

Device: During Tele-expertise

Before tele-expertise

Usual (on site) frozen section

Interventions

During Tele-expertiseDEVICE

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 who need a frozen section diagnosis

You may qualify if:

All patients

You may not qualify if:

None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Assistance Publique - Hôpitaux de Parislead
Agence Regionale de Sante d'Ile de Francecollaborator

Study Sites (6)

Service d'Anatomie pathologique. Hôpital Antoine Béclère

Clamart, 92140, France

Location

Service d'anatomie pathologique. Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Service d'anatomie pathologique. Hôpital de Raincy-Montfermeil

Montfermeil, 93370, France

Location

Service d'ORL. Hôpital du Raincy-Montfermeil

Montfermeil, 93370, France

Location

Service d'anatomie pathologique. Hôpital Saint Antoine

Paris, 75012, France

Location

Service de chirurgie viscérale. Hôpital des Diaconnesses

Paris, 75012, France

Location

Related Publications (3)

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.
PMID: 22297471BACKGROUND
Tetu 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.
PMID: 22233700BACKGROUND
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.
PMID: 26857558DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue

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

February 23, 2015

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

FR(6)

Assessment of Tele-expertise for Frozen Section Diagnosis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

During tele-expertise

Before tele-expertise

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (3)

Related Links

Biospecimen

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

During tele-expertise

Before tele-expertise

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (3)

Related Links

Biospecimen

Study Officials

Study Design

Study Record Dates

Locations