NCT06673680

Brief Summary

do colposcopy and cervical punch biopsy then compare between findings

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

October 23, 2024

Last Update Submit

November 1, 2024

Conditions

Keywords

screening in cancer cervix

Outcome Measures

Primary Outcomes (1)

  • comparison between colposcopic findings of suspicious cervix and histopathologic findings

    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

Study Arms (1)

colposcopic evaluation

do colposcopy and cervical punch biopsy then compare between findings

Device: Do colposcopy and cervical punch biopsy then compare between findings

Interventions

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.

colposcopic evaluation

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsstudy use colposcope in screening of cancer cervix
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Hazem A prof, MD

    Sohag university hospitals

    STUDY DIRECTOR

Central Study Contacts

Omar K Mohamed, master

CONTACT

Mohamed K engineer, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

October 23, 2024

First Posted

November 5, 2024

Study Start

October 1, 2024

Primary Completion

February 28, 2025

Study Completion

May 30, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations