INTER-PATHOLOGIST READER STUDY

NCT ID: NCT06246903

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-08-01

Brief Summary

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This is a post study histology analysis from previously obtained pathology slides.

Detailed Description

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This is a post study histology analysis. Pathologists will use digital histology slide scans of suspicious nevus/nevi obtained from previously conducted studies to provide histopathology gradations of histological features as outlined in the Orlucent histology atlas (LBL0713 Histopathology Atlas for Grading of Dysplastic Nevi and DEF0713-1 Histopathology Definitions for LBL0713).

Conditions

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Nevi, Dysplastic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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suspicious nevus/nevi

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Histology scans must have been obtained from previous consented subjects that allows post study ad hoc analyses.
2. Histology scans must be available from the data collected from the Orlucent OMS002, SFI001 or SFI003 Studies and are of good quality.

Exclusion Criteria

* NA
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlucent, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cathy Shachaf, PhD

Role: STUDY_DIRECTOR

Founder and President

Locations

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University of Utah Hospital, Pathology

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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SFI006

Identifier Type: -

Identifier Source: org_study_id

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