Clinical trial · Interventional
Patient Compliance to Self-collection for Detection of HPV-DNA
Patient Compliance to Self-collection for Detection of HPV-DNA in Cervical Cancer Prevention: A Clinical Trial
NCT02431520CI-TRIAL-00017802completedN/AClinicalTrials.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)
A study to investigate the compliance of unassisted women to self-collection of specimens for Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.
Conditions
Conditions (2)
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 |
| Compliance | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gynecologist collection | Procedure | — | UNRESOLVED |
| Self-collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-collection
- description
- Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for Hybrid Capture II (HCII).
- interventionNames
- Procedure: Self-collection
- type
- ACTIVE_COMPARATOR
- label
- Gynecologist collection
- description
- Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
- interventionNames
- Procedure: Gynecologist collection
Primary outcomes (1)
- measure
- Compliance to self-collection for detection of HPV-DNA measured by the percentage of subjects that returned the vaginal self-collected sample or attended to the medical appointment according to allocation.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Women between 25-59 years-old * Not pregnant * Had held their last Pap smear for over a year * Could read. Exclusion Criteria: * Women with previous hysterectomy * History of cervical cancer or its precursors * Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases) * Those who underwent self-collection of their specimen during menstrual period
References
Publications (9)
- BACKGROUNDBrink AA, Meijer CJ, Wiegerinck MA, Nieboer TE, Kruitwagen RF, van Kemenade F, Fransen Daalmeijer N, Hesselink AT, Berkhof J, Snijders PJ. High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. J Clin Microbiol. 2006 Jul;44(7):2518-23. doi: 10.1128/JCM.02440-05. PMID 16825374
- BACKGROUNDCuzick J. Human papillomavirus testing for primary cervical cancer screening. JAMA. 2000 Jan 5;283(1):108-9. doi: 10.1001/jama.283.1.108. No abstract available. PMID 10632290
- BACKGROUNDDzuba IG, Diaz EY, Allen B, Leonard YF, Lazcano Ponce EC, Shah KV, Bishai D, Lorincz A, Ferris D, Turnbull B, Hernandez Avila M, Salmeron J. The acceptability of self-collected samples for HPV testing vs. the pap test as alternatives in cervical cancer screening. J Womens Health Gend Based Med. 2002 Apr;11(3):265-75. doi: 10.1089/152460902753668466. PMID 11988136
- BACKGROUNDGontijo RC, Derchain SF, Montemor EB, Sarian LO, Serra MM, Zeferino LC, Syrjanen KJ. [Pap smear, hybrid capture II, and visual inspection in screening for uterine cervical lesions]. Cad Saude Publica. 2005 Jan-Feb;21(1):141-9. doi: 10.1590/s0102-311x2005000100016. Epub 2005 Jan 28. Portuguese. PMID 15692647
- BACKGROUNDHarper DM, Hildesheim A, Cobb JL, Greenberg M, Vaught J, Lorincz AT. Collection devices for human papillomavirus. J Fam Pract. 1999 Jul;48(7):531-5. PMID 10428251
- BACKGROUNDWikstrom I, Stenvall H, Wilander E. Attitudes to self-sampling of vaginal smear for human papilloma virus analysis among women not attending organized cytological screening. Acta Obstet Gynecol Scand. 2007;86(6):720-5. doi: 10.1080/00016340701303747. PMID 17520406
- BACKGROUNDWright TC Jr, Denny L, Kuhn L, Pollack A, Lorincz A. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. JAMA. 2000 Jan 5;283(1):81-6. doi: 10.1001/jama.283.1.81.