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NCT Number: NCT07113379

Study for Prevention of Cervical Cancer in Spain

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 2019-2024

    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.

Secondary outcomes

  1. Percentage of HPV vaccination and screening coverage by region and demographic factors

    Time frame: 2019-2024

    This objective aims to determine the proportion of individuals who have received HPV vaccination and/or undergone cervical cancer screening, stratified by geographic region and key demographic factors such as age and ethnicity. The goal is to identify disparities in preventive healthcare access.

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

    Time frame: 2019-2024

    This objective seeks to evaluate how misinformation and socioeconomic factors (income level, education, employment status, and healthcare access) influence the rates of HPV vaccination and participation in cervical cancer screening programs.

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

    Time frame: 2019-2014

    This objective aims to identify and categorize the most commonly reported barriers that individuals face when trying to access to HPV vaccination and screening programs.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Acronym: REVIVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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