NCT04061967

Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.

Recruiting now NA Last updated 14 January 2025

What this trial tests

NA trial testing Sending of screening summon. in Cervical Cancer in 20,000 participants. Currently enrolling.

Timeline

19 August 2019

Primary endpoint
1 June 2030

1 June 2030

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20,000
Start date	19 August 2019
Primary completion	1 June 2030
Estimated completion	1 June 2030
Sites	6 locations across Sweden

Drugs / interventions tested

• Sending of screening summon.

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Uterine Cervical Neoplasm — all drugs for Uterine Cervical Neoplasm →
• Uterine Neoplasms — all drugs for Uterine Neoplasms →
• Genital Neoplasm — all drugs for Genital Neoplasm →

Sponsor

Karolinska Institutet

Who can join

Adults 33 to 75, female only, with Cervical Cancer or Uterine Cervical Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken).

Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A pilot study of risk-stratified cervical cancer screening.
   Wang J, Elfström KM, Borgfeldt C, Dillner J. · · 2021 · cited 4× · PMID 37645164 · DOI 10.12688/openreseurope.13398.2
2. Nationwide registry-based trial of risk-stratified cervical screening.
   Arroyo Mühr LS, Wang J, Hassan SS, Yilmaz E, et al · · 2025 · cited 2× · PMID 39146489 · DOI 10.1002/ijc.35142