ClinicalTrials.gg
WithdrawnNCT03150745Updated Jul 31, 2024

Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

An interventional study of 3- Cervical Pap smears and Colposcopic examination in Cervical Dysplasia, sponsored by Assiut University. Withdrawn at 1 site in Egypt. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled May 2016, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Female
01

Study summary

Endocervix (cervical canal) is the cavity of the cervix and connects the external os with the internal os. It is fusiform in shape and has posterior and anterior oblique longitudinal ridges, the plicae palmatae. These are not exactly apposed but inter-lock like a zipper so that the canal is kept closed.

The original squamous epithelium is clearly identified as a smooth, usually featureless covering of the cervix; its uniform pink color contrasts with the redness of the original columnar epithelium. It joins the latter at the original squamocolumnar junction.

Many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities. Such abnormalities as ectropion, Nabothian cysts, and small cervical polyps are quite benign and need not generate concern for patient or clinician, whereas others, including those associated with a history of exposure to diethylstilbestrol, cervical inflammation, abnormal cervical cytology, and postcoital bleeding, should prompt additional evaluation. Further, in some patients, the cervix may be difficult to visualize. Several useful clinical suggestions for the optimal examination of the cervix are presented.

02

Conditions studied

  • Cervical Dysplasia
03

In context

Uterine Cervical Dysplasia

367 studies on the registry are indexed under Uterine Cervical Dysplasia; 70 are open to participants now.

Browse Uterine Cervical Dysplasia studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Suspicious cervix
  2. Age between 20 to 60 years

Exclusion criteria

Exclusion Criteria:

  1. Previously diagnosed cervical lesions.
  2. Pregnant women.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Colposcopic group

    Procedure: 3- Cervical Pap smears · Procedure: Colposcopic examination

  • Other
    office hysteroscopic group

    Procedure: 3- Cervical Pap smears · Procedure: Office hysteroscopy

Interventions

  • Procedure3- Cervical Pap smears

    Cervical Pap smears will be obtained using the long tip of an Ayre's spatula that will be placed in the endocervical canal with the proximal bulge resting on the ectocervix. The spatula will be carefully rotated around the cervix so that a representative sample of the whole cervix will be obtained. An additional endocervical sample will be obtained by placing a cytobrush or by the other end of the Ayer's spatula in the endocervical canal and gently rotated through 360 degrees as previously described. The samples will be then immediately plated on a slide, fixed by immersing the slide in 95% ethyl alcohol fixative for 15 to 20 minutes and stained by modified Papanicolaou stain using a hand staining procedure

  • ProcedureColposcopic examination

    0.9% saline technique to assess the cervical lesion and vasculature of the cervix, 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment using (Bossman forceps or endocervical speculum or counter pressure with Q stick). e- Biopsy using the punch biopsy forceps. Biopsy will be obtained from every abnormal colposcopic examination

  • ProcedureOffice hysteroscopy

    0.9% saline technique to assess the cervical lesion and vasculature of the cervix. 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment. Endometrial cavity evaluation whenever possible. Biopsy. Biopsy will be obtained from every abnormal hysteroscopic examination.

06

What researchers measure

Primary outcomes

  1. The sensitivity of office hysteroscopy detection of cervical lesions

    Time frame: 1 week

  2. The sensitivity of colposcopy

    Time frame: 1 week

07

Study locations

1 site
  • Women Health Hospital - Assiut university
    Asyut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03150745
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Lecturer of obstetrics and gynecology, Assiut University) — Principal investigator
First posted
May 12, 2017
Start date
May 2016
Primary completion
Jun 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
Jul 31, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion