AzTrials
AzTrials

Cervical CancerPCCCPNCT03757299

Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

A study testing HPV Test in people with Cervical Cancer, run by Prof. Patrick Petignat at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
HPV Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,473 participants
Where
1 siteSwitzerland
Study dates
1 Oct 2018to 9 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Geneva

    Geneva, 1205

Other trials in Switzerland

About this study

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).

Read more

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.

Conditions
Cervical Cancer
Being tested
HPV Test
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV TestDiagnostic test

    Also called VIA/VILI,, Pap smear,, Cervical biopsy, ECC

    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%.

Study groups in NCT03757299
Study groupRoleWhat they receive
Self HPVExperimentalNot described
Receives: Diagnostic Test: HPV Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard

    Measured: 3 - 5 years

Secondary outcomes (14)

  1. Prevalence of HPV infection

    HPV self-test analysed by GeneXpert machine

    Measured: 3 - 5 years

  2. Prevalence of cervical pre-cancer and cancer among Cameroonian women

    Histological analyses of cervical biopsies and endocervical brushing

    Measured: 3 - 5 years

  3. HPV clearance

    Measured by self HPV performed at 6 and 12 months follow up

    Measured: 3 - 5 years

  4. Persistance of CIN2+ disease at the 12-month follow-up

    Histological analyses of cervical biopsies and endocervical brushing

    Measured: 3 - 5 years

  5. Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)

    images database

    Measured: 3 - 5 years

  6. 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).

    Measured: 3 years

  7. Proportion of side effects and complications after thermoablation or LEEP

    questionnaire

    Measured: 3 - 5 years

  8. VIA test-positive rate (HPV-positive women);

    VIA/VILI is assessed by pelvic examination

    Measured: 3 - 5 years

  9. VIA test-positive rate after 1- year follow-up of VIA-negative tests

    VIA/VILI is assessed by pelvic examination

    Measured: 3 - 5 years

  10. 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

    Measured: 3 - 5 years

  11. 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)

    Measured: 3 years

  12. Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,

    SF12, Asex, STAI 6 Y-form

    Measured: 2 years

  13. Number of women screened with and without community health care workers.

    community health workers registre

    Measured: 2 years

  14. Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,

    questionnaire

    Measured: 3-5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2018
  2. Study start1 Oct 2018
  3. Primary completion5 Dec 2022
  4. Study completion9 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4,473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03757299
Sponsor's protocol ID
2017-01110
Other IDs
2017
Acronym
PCCCP
Status last verified
Jan 2025
First submitted
14 Nov 2018
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sormani J, Moukam A, Wisniak A, Yakam V, Schmidt NC, Kenfack B, Petignat P. Psychological and sexual impact of human papillomavirus screening in women in Cameroon: a prospective cohort study. BMC Womens Health. 2025 Dec 19;25(1):602. doi: 10.1186/s12905-025-04083-6.

    PubMed 41420163

  • Broquet C, Vassilakos P, Ndam Nsangou FM, Kenfack B, Noubom M, Tincho E, Jeannot E, Wisniak A, Petignat P. Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy. BMJ Open. 2022 Dec 22;12(12):e057234. doi: 10.1136/bmjopen-2021-057234.

    PubMed 36549727

  • 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.

    PubMed 35379615

  • 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.

    PubMed 35109806

Questions about this trial

What is this clinical trial studying?

A study testing HPV Test in people with Cervical Cancer, run by Prof. Patrick Petignat at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03757299, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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