Clinical trial · Interventional
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology (ASC-H+) and Negative Colposcopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
cervical cancer is the fourth most frequent cancer in women worldwide and in Brazil, it occupies the third position for the triennium 2020/2022, with a high mortality rate and maintained in the last 10 years. It is associated with persistent human papillomavirus (HPV) infection. Primary prevention can be accomplished through vaccines that prevent HPV infection of the epithelial cells of the cervix. Secondary prevention in screening for precursor lesions through periodic repeat cervical sampling in a population of asymptomatic women. Women with abnormal cytology are more likely to have pre-invasive or invasive lesions and are referred for further testing, colposcopy. Colposcopy identifies suspicious areas and guides the best site for biopsy. In the situation of negative colposcopy and abnormal cytology, suspicion for high-grade lesion (HSIL). It recommends further investigation of the endocervical canal before the possible excisional procedure and obtaining an additional canal sample by brushing or curettage. However, to date, there is no consensus and studies lack consistent results on which is the best method for further investigation of the endocervix. Objectives: To compare the performance of additional strategies in the investigation and detection of precursor or invasive lesions in the endocervical canal in women with abnormal cytology (ASC H+) and with initial colposcopy without suspicious images.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Diagnoses Disease | — | UNRESOLVED | — |
| HSIL of Cervix | High Grade Cervical Squamous Intraepithelial Neoplasia | ALIAS | 0.90 |
| Screening | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocervical cell block | Diagnostic Test | — | UNRESOLVED |
| Endocervical curettage | Diagnostic Test | — | UNRESOLVED |
| Endocervical liquid-base cytology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Endocervical cytology performed by liquid-based cytology
- description
- Endocervical sample collected by brushing and preserved in a liquid base, and evaluated as cytology.
- interventionNames
- Diagnostic Test: Endocervical liquid-base cytology
- type
- ACTIVE_COMPARATOR
- label
- Endocervical cell block from a canal sample preserved in a buffered formalin base
- description
- Endocervical sample collected by brushing and preserved in a buffered formalin base for obtaining a "cell block", and evaluated similarly as histology.
- interventionNames
- Diagnostic Test: Endocervical cell block
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * women aged 25 years or older with altered cytology (ASC-H+) and attended the care unit and who consented to participate in the study by signing the Informed Consent Form * Non-pregnant Exclusion Criteria: * colposcopy with abnormal findings; * total hysterectomy (extirpation of the cervix); * cervical stenosis or imperviousness near the external orifice.
References
Publications (16)
- BACKGROUNDLei J, Ploner A, Elfstrom KM, Wang J, Roth A, Fang F, Sundstrom K, Dillner J, Sparen P. HPV Vaccination and the Risk of Invasive Cervical Cancer. N Engl J Med. 2020 Oct 1;383(14):1340-1348. doi: 10.1056/NEJMoa1917338. PMID 32997908
- BACKGROUNDPossati-Resende JC, Fregnani JH, Kerr LM, Mauad EC, Longatto-Filho A, Scapulatempo-Neto C. The Accuracy of p16/Ki-67 and HPV Test in the Detection of CIN2/3 in Women Diagnosed with ASC-US or LSIL. PLoS One. 2015 Jul 31;10(7):e0134445. doi: 10.1371/journal.pone.0134445. eCollection 2015. PMID 26230097
- BACKGROUNDWalboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. doi: 10.1002/(SICI)1096-9896(199909)189:13.0.CO;2-F. PMID 10451482
- BACKGROUNDBurd EM. Human papillomavirus and cervical cancer. Clin Microbiol Rev. 2003 Jan;16(1):1-17. doi: 10.1128/CMR.16.1.1-17.2003. PMID 12525422
- BACKGROUNDSmith JS, Lindsay L, Hoots B, Keys J, Franceschi S, Winer R, Clifford GM. Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update. Int J Cancer. 2007 Aug 1;121(3):621-32. doi: 10.1002/ijc.22527. PMID 17405118
- BACKGROUNDMunoz N, Bosch FX, Castellsague X, Diaz M, de Sanjose S, Hammouda D, Shah KV, Meijer CJ. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int J Cancer. 2004 Aug 20;111(2):278-85. doi: 10.1002/ijc.20244. PMID 15197783
- BACKGROUNDZeferino LC, Derchain SF. Cervical cancer in the developing world. Best Pract Res Clin Obstet Gynaecol. 2006 Jun;20(3):339-54. doi: 10.1016/j.bpobgyn.2006.01.018. Epub 2006 Mar 24.