Clinical trial · Observational
Mobile High-Resolution Microendoscopy (mHRME) for the Detection of Cervical Dysplasia in El Salvador
NCT04472455CI-TRIAL-00045975completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Evaluate the performance of the mHRME in a study of 3,000 women in San Salvador to assess whether mHRME imaging improves specificity of screening by VIA or HPV DNA without reducing sensitivity for cervical precancer and cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRME | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Screen Negative Group
- description
- All women who screen negative at Visit 1.
- interventionNames
- Diagnostic Test: HRME
- label
- Screen Positive Group
- description
- All women who screened positive at Visit 1 and were invited to Visit 2
- interventionNames
- Diagnostic Test: HRME
- label
- 10% Of Screen Negative Group
- description
- 10% of women who screened negative at Visit 1 and were invited to Visit 2
- interventionNames
- Diagnostic Test: HRME
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women who are between the ages of 30 and 49 years of age 2. All women must have a negative urine or serum pregnancy test prior to any study procedure (within 7 days) 3. Intact cervix (patients who have undergone previous LEEP, cone and/ or cryotherapy are not eligible) 4. No history of invasive cervical cancer 5. Able and willing to provide informed consent Exclusion Criteria: 1. Women \< 30 years of age or over 49 years of age 2. Women who have undergone a hysterectomy with removal of the cervix 3. Women who have had a previous LEEP, Cold knife cone and/or cryotherapy 4. Women who are pregnant or breastfeeding 5. Women with a history of invasive cervical cancer 6. Unable or unwilling to provide informed consent
References
Publications (30)
- BACKGROUNDPapanicolaou GN, Traut HF. The diagnostic value of vaginal smears in carcinoma of the uterus. 1941. Arch Pathol Lab Med. 1997 Mar;121(3):211-24. No abstract available. PMID 9111103
- BACKGROUNDJemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. PMID 21296855
- 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
- BACKGROUNDFUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741. PMID 17494925
- BACKGROUNDPaavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6. PMID 19586656
- BACKGROUNDChou B, Krill LS, Horton BB, Barat CE, Trimble CL. Disparities in human papillomavirus vaccine completion among vaccine initiators. Obstet Gynecol. 2011 Jul;118(1):14-20. doi: 10.1097/AOG.0b013e318220ebf3. PMID 21691158
- BACKGROUNDCenters for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years--United States, 2008. MMWR Morb Mortal Wkly Rep. 2009 Sep 18;58(36):997-1001.