NCT06915610: JANUS

Reengineering Cervical Cancer Screening for the 21st Century: Joint Action for a Novel Up-to-date and Sustainable Screening Program

ENROLLING BY INVITATION NA Last updated 23 April 2025

What this trial tests

NA trial testing Invitation of all participants to CCS according to the standard of care (active comparator) in Cervical Cancer Screening in 5,700 participants. Enrolling by invitation.

Timeline

10 April 2025

Primary endpoint
31 March 2027

31 March 2027

Quick facts

Lead sponsor	Instituto de Saude Publica da Universidade do Porto
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	5,700
Start date	10 April 2025
Primary completion	31 March 2027
Estimated completion	31 March 2027
Sites	1 location across Portugal

Drugs / interventions tested

• Invitation of all participants to CCS according to the standard of care (active comparator)
• Invitation of all participants to CCS through self-sampling
• Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care
• Invitation of all participants to CCS according to the standard of care, followed by invitation of those non-adherent to CCS through self-sampling
• Invitation of all participants to CCS through self-sampling, followed by invitation of those non-adherent to CCS according to the standard of care
• Invitation of all participants to CCS, asking them to choose between self-sampling and the standard of care; this mode of invitation is repeated when participants do not adhere to the first invitation

Conditions studied

• Cervical Cancer Screening — all drugs for Cervical Cancer Screening →

Sponsor

Instituto de Saude Publica da Universidade do Porto

Who can join

Adults 30 to 69, female only, with Cervical Cancer Screening. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cervical cancer screening (CCS) is important to prevent and control cervical cancer (CC). In Portugal, CCS starts with the assessment of the presence of Human Papillomavirus (HPV) in cervical-vaginal samples, collected by a health professional. However, self-sampling (self-collection of vaginal samples by the participants in CCS), is being considered in several settings, aiming to improve participation in CCS, while also exploring its potential to reduce costs.

The goal of this study is to learn how self-sampling could be introduced in the CCS program in Portugal, by testing different strategies to combine the self-collection of samples with the collection of samples by a health professional, which is currently the standard of care.

Researchers will conduct a study comparing the following ways of conducting CCS:

* Sample collection by health professionals - SOC;
* Self-sampling - SS;
* Asking the participants if they prefer to collect their own samples, or to have the samples collected by a health professional, and then proceed as they prefer - CHOICE.

After assessing the adherence to CCS in each of the groups define above, the participants will be given the possibility to participate through a method different from the initially proposed or chosen, as follows:

* SOC will be complemented with invitation for SS;
* SS will be complemented with invitation for the SOC;
* CHOICE participants will be invited again to CHOICE, being given a new opportunity to choose how they prefer to be screened.

This study design allows for comparisons between these groups, to understand how using these strategies alone and complementarily works, and also for comparisons within each group, to understand how one strategy being used on the top of the previous may contribute to increase adherence to screening. The researchers will additionally collect information of the adherence to CCS in the year before the study is conducted, to be used as an additional benchmark.

For a better understanding on the potential barriers and facilitators to incorporating self-sampling in the CCS program, this study will also comprise interviews with the health professionals involved in the study, as well as with females eligible for screening who had been invited to participate.

Depending on the results of HPV testing and complementary cytological evaluations, participants may be referred for further assessment, according to the standard of care in the Portuguese National Health Service. This study will address the possibility of improving the yielding of the referral for further assessment, by testing, in parallel to the current standard of care, a method that is expected to contribute to reducing the number of referrals of false-positives.

Therefore, this study is expected to provide evidence based on different methods of assessment, showing the extent to which SS may contribute to improve adherence do CCS, and testing new methods that may reduce the referral of false-positives for further assessment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.