Cancer CervixNCT06673680
Role Of Colposcopy In Evaluation Of Suspicious Cervix
An observational study of Cancer Cervix, run by Sohag University at 1 site in Egypt.
Trial summary
do colposcopy and cervical punch biopsy then compare between findings Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Cervix
- What is being tested?
- Do colposcopy and cervical punch biopsy then compare between findings
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Women having active vaginal bleeding.
- Any past treatment for cervical lesions.
- Women having frank growth of cervix.
- Women who underwent a hysterectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
do colposcopy and cervical punch biopsy then compare between findings
Read the 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.
- Conditions
- Cancer Cervix
- Being tested
- Do colposcopy and cervical punch biopsy then compare between findings
- Keywords
- screening in cancer cervix
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Do colposcopy and cervical punch biopsy then compare between findingsDevice
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 group | Role | What they receive |
|---|---|---|
| colposcopic evaluation | do colposcopy and cervical punch biopsy then compare between findings Receives: Device: Do colposcopy and cervical punch biopsy then compare between findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Oct 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CervixStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Kamal Mohamed, Sohag University
- Investigators
- Hazem A prof, MD, Study director, Sohag university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673680
- Sponsor's protocol ID
- colposcopy in cancer cervix
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Colposcopy In Evaluation Of Suspicious Cervix
- ClinicalTrials.gov ID
- NCT06673680
- Acronym / sponsor ID
- colposcopy in cancer cervix
- Conditions
- Cancer Cervix
- Keywords
- screening in cancer cervix
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
do colposcopy and cervical punch biopsy then compare between findings
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colposcopic evaluation | – | Device: Do colposcopy and cervical punch biopsy then compare between findingsdo colposcopy and cervical punch biopsy then compare between findings |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnant women
- Women having active vaginal bleeding.
- Any past treatment for cervical lesions.
- Women having frank growth of cervix.
- Women who underwent a hysterectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Do colposcopy and cervical punch biopsy then compare between findingsThe 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. | Device | colposcopic evaluation |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hazem A prof, MD study director
Sohag university hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Cervix, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar K Mohamed, master (+201022827251 ext. +201225889053, kamalo.omar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between colposcopic findings of suspicious cervix and histopathologic findings (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.