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Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

NCT03873376CompletedNAINTERVENTIONAL

Summary

The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance.

Key Facts

Lead Sponsor

Oslo University Hospital

Enrollment

5669

Start Date

2019-03-11

Completion Date

2020-02-28

Study Type

INTERVENTIONAL

Official Title

A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

Interventions

Opt-in; Receive offer to order self-sampling kitOpt-out; Receive self-sampling kit unsolicitedControl; Receive open reminder to be screened by physician

Conditions

Cervical Cancer

Eligibility

Age Range

35 Years – 69 Years

Sex

FEMALE

Inclusion Criteria:

* Women living in the regions Hordaland, Vest-Agder, Rogaland or Sør-Trøndelag, who have been eligible for screening in Norway, but who have not attended screening for at least 10 years (2009-2018)

Exclusion Criteria:

* Women who have not been eligible for cervical cancer screening during the entire 10 year period (2009-2018)

Outcome Measures

Primary Outcomes

Screening attendance rate (%)

The primary outcome measure is the attendance rate to cervical cancer screening. Attendance is defined as returning a self-sampling test, or being screened by a physician during the 6 months following receipt of the invitation letter

Time frame: 6 months

Secondary Outcomes

Prevalence of high-risk HPV (%)

Self-samples as well as physician-taken samples will be tested for high-risk HPV with the Cobas 4800 HPV-DNA test at the national HPV reference laboratory

Time frame: 6 months

Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse)

Histologically confirmed CIN2+ diagnoses of all study participants who are eligible for follow-up will be retrieved from the cervical screening registry at the Cancer Registry of Norway

Time frame: 6 months

Compliance to clinical follow-up of a high-risk HPV positive screening test (%)

Attendance to follow-up among women with a positive screening test will be surveyed following notification of the positive test result. In addition to comparing arms, we will compare compliance of women in the self-sampling arms who are followed up by their regular GP vs. women who are followed up by a gynecologist

Time frame: 6 months

Locations

Cancer Registry of Norway, Oslo, Norway

Linked Papers

2022-08-23

HPV self-sampling among long-term non-attenders to cervical cancer screening in Norway: a pragmatic randomised controlled trial

Abstract Background Cervical cancer screening participation is suboptimal in most settings. We assessed whether human papillomavirus (HPV) self-sampling may increase screening participation among long-term non-attenders in Norway. Methods A pragmatic randomised controlled trial with participation as the primary outcome was initiated in the national cervical screening programme in March 2019. A random sample of 6000 women aged 35–69 years who had not attended screening for at least 10 years were randomised 1:1:1 to receive either (i) a reminder to attend regular screening (control), (ii) an offer to order a self-sampling kit (opt-in) for HPV testing or (iii) a self-sampling kit unsolicited (send-to-all) for HPV testing. Results Total participation was 4.8%, 17.0% and 27.7% among control, opt-in and send-to-all ( P < 0.0001; participation difference (%) send-to-all vs. control: 22.9 (95%CI: 20.7, 25.2); opt-in vs. control: 12.3 (95%CI: 10.3, 14.2); send-to-all vs. opt-in: 10.7 (95% CI: 8.0, 13.3)). High-risk HPV was detected in 11.5% of self-samples and 9.2% of clinician-collected samples ( P = 0.40). Most women (92.5%) who returned a positive self-sample attended the clinic for triage testing. Of the 933 women screened, 33 (3.5%) had CIN2 + (1.1%, 3.7%, 3.8% among control, opt-in, and send-to-all, respectively), and 11 (1.2%) had cervical cancer (0%, 1.2%, 1.3% among control, opt-in, send-to-all, respectively). Conclusion Opt-in and send-to-all self-sampling increased screening participation among long-term, higher-risk non-attenders. Clinical trial registration ClinicalTrials.gov NCT03873376.

Linked Investigators

Gunvor Aasbø

Mari Nygård

Tone Bjørge