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Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine

NCT07275333RecruitingNAINTERVENTIONAL

Summary

In 2020, a cervical screening center was established in Zaporizhzhia (Ukraine), initiating a pilot project to evaluate the prevalence of HPV among women in Eastern Ukraine. The findings were intended to lay the groundwork for the Ukrainian Ministry of Health in establishing a structured national screening program. However, all efforts were halted due to the nearby armed conflict, situated just 40 kilometers from the border. The World Health Organization's goal to eliminate cervical cancer globally has a gap when it comes to managing cancer control during crises like armed conflicts. We propose a demonstration project to assess whether a simpler, yet modern, cervical cancer control strategy (based on using self-sampling for HPV detection) could also be effective for cervical cancer screening in Zaporizhzhia. Women aged 30-60 years who have not had a recent negative HPV test will be invited to participate. Participants receive a self-sampling kit from their primary care provider and can return the sample free of charge to the clinic or community volunteers. All samples are analyzed in accredited laboratories in Zaporizhzhia. HPV-positive women will receive follow-up care according to national guidelines, including referral to gynecologists for additional tests and treatment if needed. HPV-negative women will be reassured and advised on future screening intervals. The study also evaluates how well the screening program can be implemented during conflict conditions. This includes measuring women's acceptance of self-sampling, the willingness of providers to adopt the procedures, and whether the screening process is feasible, practical, and sustainable. Additional process evaluation will explore how the program adapts to challenges such as migration, disrupted health services, and safety concerns. This project is conducted through collaboration between Zaporizhzhia State Medical and Pharmaceutical University, the Charitable Foundation "World Against Cancer," and Karolinska Institutet in Sweden, which provides quality assurance support for laboratory procedures. The goal is to establish a safe, effective, and sustainable cervical cancer screening model that can be used in conflict-affected regions and similar settings. This work is supported by a grant from the Union for International Cancer Control (UICC), as part of the Reimagining Cancer Research in Europe Initiative.

Key Facts

Lead Sponsor

Karolinska Institutet

Enrollment

1000

Start Date

2025-04-01

Completion Date

2026-08-31

Study Type

INTERVENTIONAL

Official Title

Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine

Interventions

HPV Self-Sampling Kit

Conditions

Cervical CancerCervical Cancer ScreeningHuman Papillomavirus (HPV) InfectionCervical Intraepithelial Neoplasia

Eligibility

Age Range

30 Years – 60 Years

Sex

FEMALE

Inclusion Criteria:

* Female aged 30-60 years
* Intact uterus (no prior hysterectomy)
* Eligible for cervical cancer screening according to local guidelines
* Able to provide informed consent
* Able to perform self-sampling at home or at a clinic

Exclusion Criteria:

* History of total hysterectomy
* Pregnancy at the time of enrollment
* Known diagnosis of cervical cancer
* Inability or unwillingness to provide informed consent
* Unable to perform self-sampling or comply with study procedures

Outcome Measures

Primary Outcomes

Uptake of HPV self-sampling among eligible women in Zaporizhzhia

Proportion of eligible women aged 30-60 who receive an HPV self-sampling kit and return a valid sample for testing. This outcome reflects the feasibility and adoption of the screening intervention during wartime conditions and directly corresponds to the project objective of improving access to cervical cancer screening through self-sampling.

Time frame: Up to 12 weeks after receipt of the self-sampling kit.

Secondary Outcomes

Acceptability of HPV self-sampling among participants

Participant acceptability measured through brief surveys and semi-structured interviews assessing comfort, ease of use, clarity of instructions, and overall satisfaction with self-sampling and follow-up procedures. Designed to evaluate acceptability according to implementation science outcomes.

Time frame: Within 4 weeks after sample return

Adoption of the screening intervention by healthcare providers

Number and proportion of primary care providers trained who offer self-sampling, register participants in the database, and report results. Includes qualitative feedback on provider experience, appropriateness, and barriers to implementation as described in the project plan.

Time frame: Up to 3 months after provider training.

Feasibility of implementing HPV self-sampling during conflict

Assessment of logistical feasibility including kit distribution pathways, sample return methods (post, clinic, NGO volunteers), laboratory capacity, screening workflow continuity, and challenges related to resource availability or security conditions. Based directly on feasibility indicators in the UICC proposal.

Time frame: At 12 months and at project completion (up to 24 months post-initiation).

Proportion of women who have never been screened prior to participation

Percentage of enrolled women who report no prior cervical cancer screening or no HPV test within the past 3 years. This evaluates reach and equity of the intervention, as outlined in the project's objectives.

Time frame: At enrollment

Performance and reliability of locally used HPV tests

Proportion of valid HPV test results and laboratory concordance based on internal quality checks and participation in the International HPV Reference Center proficiency program. This aligns with the quality assurance aims in the UICC plan.

Time frame: At annual proficiency testing cycles (0,12,18 months) and at each HPV test run (up to 24 months).

Functionality and use of the digital screening platform

Evaluation of the centralized database (selfsamplingukraine.ua), including completeness of entries, timeliness of result reporting, and usability by providers and participants. Links directly to objectives on data management and monitoring.

Time frame: At 6, 12, 18, and 24 months after platform deployment.

Follow-up completion among HPV-positive women

Proportion of HPV-positive women who complete recommended follow-up (e.g., referral to gynecologist, colposcopy, repeat HPV testing after 12 months). Reflects fidelity to follow-up protocols defined in the project plan.

Time frame: Within 2 months of a positive HPV result.

Locations

Educational and Scientific Medical Center "Universitetskaya Klinika", Zaporizhzhia State Medical and Pharmaceutical University, Zaporizhzhya, Ukraine

Linked Papers

2023-12-12

Cervical cancer screening improvements with self-sampling during the COVID-19 pandemic

Background: At the onset of the COVID-19 pandemic cervical screening in the capital region of Sweden was canceled for several months. A series of measures to preserve and improve the cervical screening under the circumstances were instituted, including a switch to screening with HPV self-sampling to enable screening in compliance with social distancing recommendations. Methods: We describe the major changes implemented, which were (1) nationwide implementation of HPV screening, (2) switch to primary self-sampling instead of clinician sampling, (3) implementation of HPV screening in all screening ages, and (4) combined HPV vaccination and HPV screening in the cervical screening program. Results: A temporary government regulation allowed primary self-sampling with HPV screening in all ages. In the Stockholm region, 330,000 self-sampling kits were sent to the home address of screening-eligible women, instead of an invitation to clinician sampling. An increase in organized population test coverage was seen (from 54% to 60% in just 1 year). In addition, a national campaign for faster elimination of cervical cancer with concomitant screening and vaccination for women in ages 23–28 was launched. Conclusions: The COVID-19 pandemic necessitated major changes in the cervical cancer preventive strategies, where it can already be concluded that the strategy with organized primary self-sampling for HPV has resulted in a major improvement of population test coverage. Funding: Funded by the Swedish Association of Local Authorities and Regions, the Swedish Cancer Society, the European Union’s Horizon 2020 Research and Innovation Program, the Swedish government, and the Stockholm county.

Linked Investigators

Joakim Dillner