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iMproving thE DIagnostics And Treatment Of ceRvical Precancer

NCT05870787CompletedOBSERVATIONAL

Summary

Cervical cancer screening is important as it enables identification of women at increased risk of the disease, but high-quality diagnostics of screen-positive women and effective treatment of those with precancer are critical in preventing progression to cancer. With the current transition from cytology-based to primary human papillomavirus (HPV)-screening and a growing proportion of HPV-vaccinated women, diagnostics of screen-positive women will become more challenging in the decades to come. Thus, there is a need to explore how to improve diagnostics while ensuring a low number of unnecessary procedures such as colposcopy and the collection of multiple cervical biopsies. The overall purposes are: Purpose 1: To investigate the diagnostic accuracy of cervical precancer when using a colposcopic scoring system in the diagnostic work-up of screen-positive women. Purpose 2: To investigate the performance of a colposcopic scoring system to identify women without cervical precancer in whom collection of biopsies can be safely omitted.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

929

Start Date

2023-03-01

Completion Date

2024-12-06

Study Type

OBSERVATIONAL

Official Title

iMproving thE DIagnostics And Treatment Of ceRvical Precancer

Interventions

Swede score colposcopy

Conditions

Cervical DysplasiaCervical DiseaseCervical LesionCervical CancerCervical Neoplasm

Eligibility

Age Range

23 Years – 99 Years

Sex

FEMALE

Inclusion Criteria:

* Women referred to colposcopy due to abnormal smear (HPV-genotype and cytology) in Central Denmark Region or Southern Denmark Region.

Exclusion Criteria:

* Allergic to iodine.
* Tranformationzone not visible (type 3).
* Atrophy of cervical epithelium.
* Women referred to colposcopy with no cervical biopsies taken or invalid cervical biopsies.
* Women with previous hysterectomy or without a cervix due to cervical cancer will be excluded.
* Pregnant women.

Outcome Measures

Primary Outcomes

Purpose 1: Diagnosis of collected targeted cervical biopsies

The number of women diagnosed with Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) diagnosed in cervical biopsies

Time frame: When the histological report is available - typically within 12 weeks after the biopsy was taken

Purpose 2: Diagnosis of collected random cervical biopsies

The number of women diagnosed with Cervical Intraepithelial Neoplasia grade 1 or less (\<CIN1) vs. (CIN2+) diagnosed in random cervical biopsies. The clinical perspectives will be the absolute risk of CIN2+ in random biopsies.

Time frame: When the histological report is available - typically within 12 weeks after the biopsy was taken

Locations

Guldberg Kvindeklinik, Fredericia, Denmark

Gødstrup Regional Hospital, Herning, Denmark

Horsens Gynækologisk Klinik, Horsens, Denmark

Horsens Regional Hospital, Horsens, Denmark

Odense Univeristy Hospital, Odense, Denmark

Randers Regional Hospital, Randers, Denmark

Viborg Regional Hospital, Viborg, Denmark

Linked Papers

2024-12-15

Assessment of a colposcopic scoring system (Swedescore) to reduce the number of cervical biopsies: a protocol for a clinical multicentre non-randomised intervention study in Denmark

Introduction Colposcopy is a standard procedure for evaluating cervical abnormalities and collecting cervical biopsies. The procedure is associated with intra- and inter-observer variation. A colposcopic scoring system, Swedescore, has been designed to standardise and facilitate colposcopy training. Swedescore has performed well in a routine clinical setting when used by expert colposcopists to find or exclude high-grade lesions. Danish clinical guidelines for colposcopy differ from other countries, as they recommend collecting four cervical biopsies in all women regardless of risk factors or colposcopy findings. Swedescore has never been examined to assess the reduction of cervical biopsies in a real-world clinical setting. This study aims to investigate whether the implementation of Swedescore can optimise the diagnostic work-up for whom the collection of biopsies can be safely omitted or reduced. Methods and analysis The design is a clinical multicentre non-randomised intervention study in Denmark. According to a power calculation, we will need to include 586 women referred for colposcopy. Colposcopy with Swedescore will be compared with conventional colposcopy with no Swedescore. Cervical biopsies will be divided into two separate vials (target and random biopsies). The primary outcome will be normal or cervical intraepithelial neoplasia grade 1 detected in cervical biopsies. χ 2 and logistic regression will be used to compare estimates between arms. Ethics and dissemination The study protocol has been submitted to the Ethical Committee in Central Denmark region and is not notifiable to the Committee (j.no.: 1-10-72-124-22). Results will be published in a peer-reviewed journal and presented at scientific meetings. Trial registration number NCT05870787 . Protocol version Version 3 (date 12. November 2024).

Linked Investigators

Ane-Kersti Skaarup Knudsen

Björn Strander

Tina Hovgaard Randrup