Study for Prevention of Cervical Cancer in Spain

NCT07113379 | Not Yet Recruiting FDA Drug

• 1 other identifier: REVIVE
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The REVIVE study aims to analyze the current status of Human Papillomavirus (HPV) vaccination programs and cervical cancer screening strategies in Spain. Its objective is to gain a comprehensive understanding of the effectiveness of these preventive measures, as well as to identify the main barriers to access and the existing inequalities in care. The study will also examine the impact of misinformation on population engagement and on the overall equity of the prevention system. Despite significant advances in both vaccination and screening efforts, cervical cancer remains a major public health concern in Spain. In 2024 alone, 2,259 new cases were diagnosed, that incidence has remained relatively stable in recent years, even decades. Mortality rates have also shown little change, with over 600 deaths annually, totaling nearly 10,000 in the last 15 years. To address this, the study plans to include approximately 200 patients diagnosed with cervical cancer in Spain between 2019 and 2024. It is a retrospective, observational, and non-interventional study. Data will be collected from existing medical records and supplemented with a specific questionnaire administered to the participating patients.

Conditions

Cervical Cancer Screening; HPV Vaccination

Outcome Measures

Primary Outcomes (1)

• Prevalence of HPV vaccination and cervical cancer screening among patients diagnosed with cervical cancer in Spain

  Proportion of individuals diagnosed with cervical cancer who have previously received the HPV vaccine and/or undergone cervical cancer screening prior to their cervical cancer diagnosis. The objective is to assess the effectiveness of national prevention strategies, identify gaps in vaccine and screening coverage, and understand potential barriers to early detection and vaccination.

  2019-2024

Secondary Outcomes (3)

• Percentage of HPV vaccination and screening coverage by region and demographic factors

  2019-2024

• Association between misinformation and socioeconomic factors and the rate of HPV vaccination and screening

  2019-2024

• Reported frequency and nature of barriers to accessing to HPV vaccination and cervical cancer screening

  2019-2014

Interventions

Evaluate the effectiveness of current Human Papillomavirus (HPV) vaccination and screening programs in reducing cervical cancer incidence in Spain. BIOLOGICAL

Data will be collected from existing medical records and supplemented with a specific questionnaire administered to the participating patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.

You may qualify if:

• Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
• Diagnosis established between 2019 and 2024.

You may not qualify if:

• Patients aged below 18 years at diagnosis.
• Diagnosis of other cervical cancer histologies (e.g., neuroendocrine tumors, sarcoma, lymphoma).
• Patents with significant cognitive impairment precluding informed consent for data utilization, where applicable.
• Patients with incomplete medical records relevant to the study variables.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

MeSH Terms

Interventions

Papillomavirus Vaccines; Vaccination

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 8, 2025
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-07