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Prevention and Screening Towards Elimination of Cervical Cancer

NCT05234112CompletedNAINTERVENTIONAL

Summary

The research project applies the protocol of the World Health Organisation for screening of cervical cancer, with testing of hrHPV as first screening, followed by Visual Inspection of the cervix with Acetic Acid for hrHPV-positive women and for women with minor lesions thermo-ablation of affected areas. This procedure is applied in Uganda, India and Bangladesh. In Slovakia hrHPV-positive women are offered Pap-smear and for women with Pap IV lis excision.

Key Facts

Lead Sponsor

University Medical Center Groningen

Enrollment

30000

Start Date

2022-09-15

Completion Date

2023-12-30

Study Type

INTERVENTIONAL

Official Title

Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer

Interventions

Community mobilisation for hrHPV self-testinghrHPV self-testingFollow-up after testingVIAThermo-ablation or cryotherapy for dysplasiaPap smear cytology

Conditions

HPV InfectionCervix CancerCervical Dysplasia

Eligibility

Age Range

30 Years – 60 Years

Sex

FEMALE

Inclusion Criteria:

* Female in eligible age group
* Ability to give informed consent and participate in study

Exclusion Criteria:

* Clinical signs of cervical carcinoma
* Menstruation or other vaginal blood loss

Outcome Measures

Primary Outcomes

Uptake of hrHPV self-test in community

Percentage of eligible women who take self-test out of women who have been offered self-test for hrHPV

Time frame: One week between approaching eligible women and collecting self-test

Coverage of hrHPV self-test in community

Percentage of women who take self-test out of women in geographical area eligible for self-test for hrHPV.

Time frame: 18 months between start approaching women in geographical area and closing screening operations in that area

Uptake of VIA or Pap-smear of eligible women

Percentage of women who are hrHPV-positive and are invited for VIA or Pap-smear who actually undergo the procedure

Time frame: One month between communicating hrHPV test result and measuring attendance in clinic for VIA or Pap-smear

Secondary Outcomes

Implementation fidelity of screening protocol

Percentage of health facilities involved in the research that is capable of performing the screening protocol fully (both human resources capacity as equipment and supplies

Time frame: 24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility

Sustainability of screening protocol

Percentage of local, district, regional health organisations involved in the study, that is able to maintain the screening protocol as Integrated part of service delivery

Time frame: 24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation

Locations

Mpasana, Kakumiro, Uganda

Linked Papers

2022-07-15

Investigating feasibility of 2021 WHO protocol for cervical cancer screening in underscreened populations: PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC)

Abstract Background High-risk human papillomavirus (hrHPV) testing has been recommended by the World Health Organization as the primary screening test in cervical screening programs. The option of self-sampling for this screening method can potentially increase women’s participation. Designing screening programs to implement this method among underscreened populations will require contextualized evidence. Methods PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC) will use a multi-method approach to investigate the feasibility of implementing a cervical cancer screening strategy with hrHPV self-testing as the primary screening test in Bangladesh, India, Slovak Republic and Uganda. The primary outcomes of study include uptake and coverage of the screening program and adherence to follow-up. These outcomes will be evaluated through a pre-post quasi-experimental study design. Secondary objectives of the study include the analysis of client-related factors and health system factors related to cervical cancer screening, a validation study of an artificial intelligence decision support system and an economic evaluation of the screening strategy. Discussion PRESCRIP-TEC aims to provide evidence regarding hrHPV self-testing and the World Health Organization’s recommendations for cervical cancer screening in a variety of settings, targeting vulnerable groups. The main quantitative findings of the project related to the impact on uptake and coverage of screening will be complemented by qualitative analyses of various determinants of successful implementation of screening. The study will also provide decision-makers with insights into economic aspects of implementing hrHPV self-testing, as well as evaluate the feasibility of using artificial intelligence for task-shifting in visual inspection with acetic acid. Trial registration ClinicalTrials.gov, NCT05234112. Registered 10 February 2022

Linked Investigators

Marat Sultanov