Cervical Cancer Clinical Trial
Official title:
Patient Compliance to Self-collection for Detection of HPV-DNA in Cervical Cancer Prevention: A Clinical Trial
Verified date | May 2015 |
Source | Oswaldo Cruz Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 59 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira (IFF/Fiocruz) | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Oswaldo Cruz Foundation | Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. |
Brazil,
Brink 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. — View Citation
Cuzick J. Human papillomavirus testing for primary cervical cancer screening. JAMA. 2000 Jan 5;283(1):108-9. — View Citation
Dzuba IG, Díaz EY, Allen B, Leonard YF, Lazcano Ponce EC, Shah KV, Bishai D, Lorincz A, Ferris D, Turnbull B, Hernández Avila M, Salmerón 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. — View Citation
Gontijo 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. Epub 2005 Jan 28. Portuguese. — View Citation
Harper 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. — View Citation
Mandelblatt JS, Lawrence WF, Womack SM, Jacobson D, Yi B, Hwang YT, Gold K, Barter J, Shah K. Benefits and costs of using HPV testing to screen for cervical cancer. JAMA. 2002 May 8;287(18):2372-81. — View Citation
Ogilvie G, Krajden M, Maginley J, Isaac-Renton J, Hislop G, Elwood-Martin R, Sherlock C, Taylor D, Rekart M. Feasibility of self-collection of specimens for human papillomavirus testing in hard-to-reach women. CMAJ. 2007 Aug 28;177(5):480-3. — View Citation
Wikström 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. — View Citation
Wright 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Risk of compliance to self-collection for detection of HPV-DNA in relation to collection by medical personnel | One week after inclusion | No |
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