Clinical trial · Interventional
Comparison Of Cytology And Molecular Screening For Detecting Cervical Reactive Cellular Changes In General Population
Study To Compare The Efficacy Of Cervical Cytology With Molecular Screening In The Detection Of Reactive Cellular Changes In The Cervix In An Open Population
NCT07211204CI-TRIAL-00104487withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study did not start, i.e., no participants were enrolled, because the Mexican Regulatory Authority (COFEPRIS) did not authorize the amendments to the protocol.
Summary
Brief summary (as posted)
This study compares the efficacy of cytology (Pap smear) with the molecular screening in their ability to detect reactive cellular changes in the cervix among an open population
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AGUS | — | UNRESOLVED | — |
| ASC-US | — | UNRESOLVED | — |
| Atypical Glandular Cells of Uncertain Significance | — | UNRESOLVED | — |
| Atypical Squamous Cell of Undetermined Significance | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia (CIN) | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| CIN 1 | Cervical Squamous Intraepithelial Neoplasia 1 | ALIAS | 0.90 |
| CIN 2 | Cervical Squamous Intraepithelial Neoplasia 2 | ALIAS | 0.90 |
| CIN 3 | Cervical Squamous Intraepithelial Neoplasia 3 | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colposcopy | Diagnostic Test | — | UNRESOLVED |
| Histopathology | Diagnostic Test | — | UNRESOLVED |
| HPV DNA test | Other | — | UNRESOLVED |
| Liquid-based cytology | Other | — | UNRESOLVED |
| Molecular screening | Other | — | UNRESOLVED |
| Physical examination | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Screening for reactive cellular changes in the cervix
- description
- Participants will be drawn from an open population, so they will be asymptomatic for any cervical disease. Based on colposcopy, there will be four clinical groups: negative control (CTR), low-grade squamous intraepithelial lesion (LSIL, CIN-1), high-grade squamous intraepithelial lesion (HSIL, CIN-2/3), and cervical cancer (CC).
- interventionNames
- Procedure: Physical examination
- Other: Liquid-based cytology
- Other: Molecular screening
- Other: HPV DNA test
- Diagnostic Test: Colposcopy
- type
- OTHER
- label
- Histopathology of cervical biopsy
- description
- Based on colposcopy, participants in the groups LSIL/CIN-1, HSIL/CIN-2/3, and cervical cancer (CC) will be biopsied.
- interventionNames
- Diagnostic Test: Histopathology
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Be in good general health. * Age 18-85 years. * A minimum fast of 6 hours and no more than 12 hours. * Refrain from sexual intercourse 24 hours before the study. * Give written informed consent. Exclusion Criteria: * Having a subtotal, total, or radical hysterectomy. * Being pregnant or suspected of being pregnant. A rapid urine test will be performed. If the result is positive, the patient will be excluded from the protocol and referred for prenatal care. * Being under oncological treatment (chemotherapy, radiotherapy and/or brachytherapy). * Being on their period. * Have a previous confirmatory diagnosis of HIV and/or hepatitis infection. * Having taken antiplatelet medications, e.g., acetylsalicylic acid, at least 24 hours before the study. Discontinuation Criteria: * If the participant refuses any of the study procedures. * If the study gynecologist detects that the participant has had a hysterectomy. * If the volume of the biological samples is insufficient (less than 10 mL for the blood sample).
References
Publications (37)
- BACKGROUNDSerdar CC, Cihan M, Yucel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. doi: 10.11613/BM.2021.010502. Epub 2020 Dec 15. PMID 33380887
- BACKGROUNDRozemeijer K, Penning C, Siebers AG, Naber SK, Matthijsse SM, van Ballegooijen M, van Kemenade FJ, de Kok IM. Comparing SurePath, ThinPrep, and conventional cytology as primary test method: SurePath is associated with increased CIN II+ detection rates. Cancer Causes Control. 2016 Jan;27(1):15-25. doi: 10.1007/s10552-015-0678-1. Epub 2015 Oct 12. PMID 26458884
- BACKGROUNDBell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013 Jan 21;346:e8668. doi: 10.1136/bmj.e8668. PMID 23338004
- BACKGROUNDHajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26. PMID 24582925
- BACKGROUNDDeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45. PMID 3203132
- BACKGROUNDHu ZY, Xiao L, Bode AM, Dong Z, Cao Y. Glycolytic genes in cancer cells are more than glucose metabolic regulators. J Mol Med (Berl). 2014 Aug;92(8):837-45. doi: 10.1007/s00109-014-1174-x. Epub 2014 Jun 8. PMID 24906457
- BACKGROUNDXue C, Gu X, Li G, Bao Z, Li L. Expression and Functional Roles of Eukaryotic Initiation Factor 4A Family Proteins in Human Cancers. Front Cell Dev Biol. 2021 Nov 19;9:711965. doi: 10.3389/fcell.2021.711965. eCollection 2021.