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Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon (PCCCP)

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ClinicalTrials.gov Identifier: NCT03757299
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Patrick Petignat, University Hospital, Geneva

Brief Summary:

In sub-Saharan Africa, cervical cancer is the leading cause of cancer death among women because of the difficulty in implementing screening programs. The main obstacles in these countries are poverty, lack of healthcare infrastructures and trained practitioners. With the availability of new technologies, researchers are looking for new strategies adapted to low- and middle-income countries to identify cervical precancerous lesions.

Current evidence shows that Human Papilloma Virus (HPV) testing is more effective than cytology (Pap smear) for cervical cancer screening in resource-limited settings. Indeed, the GeneXpert® HPV test offers the opportunity to prevent cervical cancer (CC) in a single visit: rapid detection of high-risk HPV (HPV) infection followed by same day treatment of HPV-positive women during the same visit (screen-and-treat approach).

However only a small proportion of HPV-positive women will develop cervical (pre)cancer, making it important to select those to treat. This triage can be achieved by colposcopy, cytology and visual inspection after application of acetic acid (VIA). Though VIA is the triage test recommended by WHO for resource-limited countries, it has not yet been widely assessed in sub-Saharan Africa (SSA).

Our main objective is to assess the performance of HPV-test followed by Visual Inspection after application of Acetic acid and Lugol's iodine VIA/VILI to detect cervical precancerous lesions in a screen-and-treat strategy in Cameroon (sub-Saharan Africa) where there is no cervical cancer-screening program.

We organized a successful free screening campaign in Cameroon in 2015 that allowed us to identify the expectations of women and their eagerness to benefit from prevention of gynecological cancers and sexually transmitted diseases.


Condition or disease Intervention/treatment Phase
Cervical Cancer Diagnostic Test: HPV Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self HPV Diagnostic Test: HPV Test
Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. Two transport mediums will be used for those self-collected vaginal samples: NaCl 0.9%.
Other Names:
  • VIA/VILI,
  • Pap smear,
  • Cervical biopsy
  • ECC




Primary Outcome Measures :
  1. Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard [ Time Frame: 3 - 5 years ]

Secondary Outcome Measures :
  1. Prevalence of HPV infection [ Time Frame: 3 - 5 years ]
  2. Prevalence of cervical pre-cancer and cancer among Cameroonian women [ Time Frame: 3 - 5 years ]
  3. HPV clearance measured by self HPV performed at 6 and 12 months follow up [ Time Frame: 3 - 5 years ]
  4. Prevalence of CIN2+ disease at the 12-month follow-up [ Time Frame: 3 - 5 years ]
  5. incidence of obstetric fistula in the areas of study [ Time Frame: 3 - 5 years ]
  6. Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database) [ Time Frame: 3 - 5 years ]
  7. Acceptability rate of self-HPV test and cervical cancer screening procedures [ Time Frame: 3 - 5 years ]
    To assess the acceptability of self-HPV, patients completed a questionnaire comprising different questions about the collection device, the easiness to collect a sample, comfort, the anxiety and the confidence of the test

  8. Proportion of side effects and complications after thermoablation or LEEP [ Time Frame: 3 - 5 years ]
  9. VIA test-positive rate (HPV-positive women); [ Time Frame: 3 - 5 years ]
  10. VIA test-positive rate after 1- year follow-up of VIA-negative tests [ Time Frame: 3 - 5 years ]
  11. Thermoablation efficacy rate [ Time Frame: 3 - 5 years ]
    Thermoablation efficacy rate will be assessed according to the biopsy proven CIN2+ rate after thermoablation treatment at the 6 and 12-month follow-up. The absence of CIN2+ will determine the success of the treatment in a patient who previously had a CIN2+ lesion

  12. Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area [ Time Frame: 3 - 5 years ]
  13. Acceptability rate of thermoablation [ Time Frame: 3 - 5 years ]
    To assess the acceptability of thermoablation, patients completed a questionnaire comprising different questions about treatment tolerance, pain and following side effects



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Ages Eligible for Study:   30 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women will be recruited by the study
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 30-49 years, able to comply with the study protocol

Exclusion Criteria:

  • Pregnancy
  • Previous total hysterectomy
  • Conditions impairing examination of the cervix

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757299


Locations
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Switzerland
University of Geneva Recruiting
Geneva, Switzerland, 1205
Contact: Patrick Petignat    +4122 37 24 432    patrick.petignat@hcuge.ch   
Sponsors and Collaborators
Prof. Patrick Petignat

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Responsible Party: Prof. Patrick Petignat, Director of the gynecology departement, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03757299     History of Changes
Other Study ID Numbers: 2017-01110
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female