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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
HPV Test
Sponsored by
Prof. Patrick Petignat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

30 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of GenevaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self HPV

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence of HPV infection
HPV self-test analysed by GeneXpert machine
Prevalence of cervical pre-cancer and cancer among Cameroonian women
Histological analyses of cervical biopsies and endocervical brushing
HPV clearance
Measured by self HPV performed at 6 and 12 months follow up
Persistance of CIN2+ disease at the 12-month follow-up
Histological analyses of cervical biopsies and endocervical brushing
Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)
images database
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).
Proportion of side effects and complications after thermoablation or LEEP
questionnaire
VIA test-positive rate (HPV-positive women);
VIA/VILI is assessed by pelvic examination
VIA test-positive rate after 1- year follow-up of VIA-negative tests
VIA/VILI is assessed by pelvic examination
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
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)
Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,
SF12, Asex, STAI 6 Y-form
Number of women screened with and without community health care workers.
community health workers registre
Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,
questionnaire

Full Information

First Posted
November 14, 2018
Last Updated
May 9, 2023
Sponsor
Prof. Patrick Petignat
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1. Study Identification

Unique Protocol Identification Number
NCT03757299
Brief Title
Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon
Acronym
PCCCP
Official Title
Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Patrick Petignat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self HPV
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV Test
Other Intervention Name(s)
VIA/VILI,, Pap smear,, Cervical biopsy, ECC
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
Description
VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard
Time Frame
3 - 5 years
Secondary Outcome Measure Information:
Title
Prevalence of HPV infection
Description
HPV self-test analysed by GeneXpert machine
Time Frame
3 - 5 years
Title
Prevalence of cervical pre-cancer and cancer among Cameroonian women
Description
Histological analyses of cervical biopsies and endocervical brushing
Time Frame
3 - 5 years
Title
HPV clearance
Description
Measured by self HPV performed at 6 and 12 months follow up
Time Frame
3 - 5 years
Title
Persistance of CIN2+ disease at the 12-month follow-up
Description
Histological analyses of cervical biopsies and endocervical brushing
Time Frame
3 - 5 years
Title
Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)
Description
images database
Time Frame
3 - 5 years
Title
Acceptability rate of self-HPV test and cervical cancer screening procedures
Description
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).
Time Frame
3 years
Title
Proportion of side effects and complications after thermoablation or LEEP
Description
questionnaire
Time Frame
3 - 5 years
Title
VIA test-positive rate (HPV-positive women);
Description
VIA/VILI is assessed by pelvic examination
Time Frame
3 - 5 years
Title
VIA test-positive rate after 1- year follow-up of VIA-negative tests
Description
VIA/VILI is assessed by pelvic examination
Time Frame
3 - 5 years
Title
Thermal ablation efficacy rate
Description
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
Time Frame
3 - 5 years
Title
Acceptability rate of thermoablation
Description
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)
Time Frame
3 years
Title
Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,
Description
SF12, Asex, STAI 6 Y-form
Time Frame
2 years
Title
Number of women screened with and without community health care workers.
Description
community health workers registre
Time Frame
2 years
Title
Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,
Description
questionnaire
Time Frame
3-5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women will be recruited by the study
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Geneva
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Petignat
Phone
+4122 37 24 432
Email
patrick.petignat@hcuge.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35379615
Citation
Petignat P, Kenfack B, Wisniak A, Saiji E, Tille JC, Tsuala Fouogue J, Catarino R, Tincho E, Vassilakos P. ABCD criteria to improve visual inspection with acetic acid (VIA) triage in HPV-positive women: a prospective study of diagnostic accuracy. BMJ Open. 2022 Apr 4;12(4):e052504. doi: 10.1136/bmjopen-2021-052504.
Results Reference
derived
PubMed Identifier
35109806
Citation
Metaxas T, Kenfack B, Sormani J, Tincho E, Lemoupa Makajio S, Wisniak A, Vassilakos P, Petignat P. Acceptability and safety of thermal ablation to prevent cervical cancer in sub-Saharan Africa. BMC Cancer. 2022 Feb 2;22(1):132. doi: 10.1186/s12885-022-09202-2.
Results Reference
derived

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Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

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