NCT04340011

Brief Summary

Images will be collected during routine colposcopy and paired with their pathology results to be used for resident education

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

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

First Submitted

Initial submission to the registry

January 13, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

January 13, 2020

Last Update Submit

April 21, 2020

Conditions

Educational ProblemsCervix, Dysplasia

Keywords

colposcopyresident education

Outcome Measures

Primary Outcomes (1)

  • Resident accuracy in identifying sites for biopsy during Colposcopy

    using colposcopic images obtained during routine patient care residents will complete quiz from images with immediate results of the test to assess the accuracy of visual cues to biopsy

    1 year

Interventions

ColposcopyOTHER

prospective resident education for colposcopy

Also known as: prospective resident education

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscolposcopy only performed in female population
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females over the age of 21 undergoing clinically indicated coposcopy that are able to give informed consent

You may qualify if:

  • ability to give informed consent
  • age 21or older
  • undergoing clinically indicated colposcopy

You may not qualify if:

  • under 21 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Leigh Cantrell, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian C Cook, MD

CONTACT

4349821719ic8ft@hscmail.mcc.virginia.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

April 9, 2020

Study Start

April 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2022

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Once pathology is confirmed 3-4 weeks post colposcopy all PHI will be removed from the participant

Locations

US(1)