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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02431520
Other study ID # 58/07
Secondary ID
Status Completed
Phase N/A
First received September 15, 2014
Last updated May 5, 2015
Start date May 2007
Est. completion date December 2007

Study information

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

Clinical Trial Summary

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.


Description:

Women living in the community of the Morro dos Macacos, Vila Isabel, Rio de Janeiro, were randomly allocated for self-collection of specimens for HC II for detection of HPV-DNA or to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.

The compliance was measured by the delivery of the specimen obtained by self-collection or to attend to a visit at the community health center to be submitted to Pap smear collection, within a week.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
Self-collection
Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.
Gynecologist collection
Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist

Locations

Country Name City State
Brazil Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira (IFF/Fiocruz) Rio de Janeiro

Sponsors (2)

Lead Sponsor Collaborator
Oswaldo Cruz Foundation Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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

Outcome

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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