Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

Cervical Cancer Clinical Trial

— PCCCP  

Official title:

Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03757299
• Other study ID #: 2017-01110
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 5, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). The main objective of the investigators 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. The investigators organized a successful free screening campaign in Cameroon in 2015 that allowed to identify the expectations of women and their eagerness to benefit from prevention of gynecological cancers and sexually transmitted diseases.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4473
• Est. completion date: December 5, 2024
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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%.

Locations

Country	Name	City	State
Switzerland	University of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Patrick Petignat

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard	VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard	3 - 5 years
Secondary	Prevalence of HPV infection	HPV self-test analysed by GeneXpert machine	3 - 5 years
Secondary	Prevalence of cervical pre-cancer and cancer among Cameroonian women	Histological analyses of cervical biopsies and endocervical brushing	3 - 5 years
Secondary	HPV clearance	Measured by self HPV performed at 6 and 12 months follow up	3 - 5 years
Secondary	Persistance of CIN2+ disease at the 12-month follow-up	Histological analyses of cervical biopsies and endocervical brushing	3 - 5 years
Secondary	Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)	images database	3 - 5 years
Secondary	Acceptability rate of self-HPV test and cervical cancer screening procedures	To assess the acceptability of self-HPV, patients complete a questionnaire comprising different questions about the collection device (embarassment, comfort, anxiety and confidence about the test).; Likert Scale 4 points : 1 (not at all) to 4 (very).	3 years
Secondary	Proportion of side effects and complications after thermoablation or LEEP	questionnaire	3 - 5 years
Secondary	VIA test-positive rate (HPV-positive women);	VIA/VILI is assessed by pelvic examination	3 - 5 years
Secondary	VIA test-positive rate after 1- year follow-up of VIA-negative tests	VIA/VILI is assessed by pelvic examination	3 - 5 years
Secondary	Thermal ablation efficacy rate	Thermal ablation 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.; Adverses event : bleeding, complications, hospitalization	3 - 5 years
Secondary	Acceptability rate of thermoablation	To assess the acceptability of thermoablation, patients completed a questionnaire comprising different questions about treatment tolerance, pain and following side effects. Respondent were invited to rate answers on a likert scale of 1 (no accpetability) to 4 (high acceptability)	3 years
Secondary	Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,	SF12, Asex, STAI 6 Y-form	2 years
Secondary	Number of women screened with and without community health care workers.	community health workers registre	2 years
Secondary	Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,	questionnaire	3-5 years