Role Of Colposcopy In Evaluation Of Suspicious Cervix

November 1, 2024 updated by: Omar Kamal Mohamed, Sohag University
do colposcopy and cervical punch biopsy then compare between findings

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to correlate colposcopy and histopathological findings in early screening of suspicious cervix and cervical cancer. And to do a colposcopic evaluation of all cervical lesions and the early detection of all cervical precancer and invasive lesions of the cervix in symptomatic women.

Study Type

Observational

Enrollment (Estimated)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed K engineer, Master
  • Phone Number: +201225889053 +201027836607
  • Email: kamalo.omar@gmail.com

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Age from 30 to 64 years old.
  • Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
  • Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
  • Women with Pap smear showing dysplasia.

Description

Inclusion Criteria:

  • Age from 30 to 64 years old.
  • Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
  • Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
  • Women with Pap smear showing dysplasia

Exclusion Criteria:

  • Pregnant women
  • Women having active vaginal bleeding.
  • Any past treatment for cervical lesions.
  • Women having frank growth of cervix.
  • Women who underwent a hysterectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
colposcopic evaluation
do colposcopy and cervical punch biopsy then compare between findings
Device: Do colposcopy and cervical punch biopsy then compare between findings
The aim of this study is to correlate colposcopy and histopathological findings in early screening of suspicious cervix and cervical cancer. And to do a colposcopic evaluation of all cervical lesions and the early detection of all cervical precancer and invasive lesions of the cervix in symptomatic women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between colposcopic findings of suspicious cervix and histopathologic findings
Time Frame: baseline
Correlate colposcopy and histopathological findings in early screening of suspicious cervix and cervical cancer. And to do a colposcopic evaluation of all cervical lesions and the early detection of all cervical precancer and invasive lesions of the cervix in symptomatic women.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Hazem A prof, MD, Sohag University hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • colposcopy in cancer cervix

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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