NCT06246903

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

June 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 30, 2024

Last Update Submit

January 30, 2024

Conditions

Nevi, Dysplastic

Outcome Measures

Primary Outcomes (1)

  • Study Success

    This is a data collection study. Study success is considered when the interpathology agreement is improved when compared to the agreement identified in Elmore et al. \[5\]. \[(classes/agreement): class I (eg, nevus or mild atypia) / 92% (95% confidence interval 90% to 94); class II (eg, moderate atypia) / 25% (22% to 28%); III (eg, severe atypia or melanoma in situ) / 40% (37% to 44%); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma) / 43% (39% to 46%); and V (eg, ≥pT1b invasive melanoma) / 72% (69% to 75%).\]

    8 months

Study Arms (1)

suspicious nevus/nevi

Eligibility Criteria

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

Previous consented subject\'s scans from the Orlucent OMS002, SFI001 or SFI003 Studies and

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Hospital, Pathology

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Dysplastic Nevus Syndrome

Condition Hierarchy (Ancestors)

NevusNevi and MelanomasNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Cathy Shachaf, PhD

    Founder and President

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

June 15, 2023

Primary Completion

June 20, 2024

Study Completion

August 1, 2024

Last Updated

February 7, 2024

Record last verified: 2024-01

Locations

US(1)