Cervical Cancer ScreeningREVIVENCT07113379
Study for Prevention of Cervical Cancer in Spain
An observational study of Cervical Cancer Screening and HPV Vaccination, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Screening, HPV Vaccination
- What is being tested?
- Evaluate the effectiveness of current Human Papillomavirus (HPV) vaccination and screening programs in reducing cervical cancer incidence in Spain.
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
Who may be able to join
- Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
- Diagnosis established between 2019 and 2024.
Who cannot join
- 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.
About this study
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
- Being tested
- Evaluate the effectiveness of current Human Papillomavirus (HPV) vaccination and screening programs in reducing cervical cancer incidence in Spain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2019-2024
Secondary outcomes (3)
Percentage of HPV vaccination and screening coverage by region and demographic factors
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.
Measured: 2019-2024
Association between misinformation and socioeconomic factors and the rate of HPV vaccination and screening
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.
Measured: 2019-2024
Reported frequency and nature of barriers to accessing to HPV vaccination and cervical cancer screening
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.
Measured: 2019-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113379
- Sponsor's protocol ID
- REVIVE
- Acronym
- REVIVE
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Prevention of Cervical Cancer in Spain
- ClinicalTrials.gov ID
- NCT07113379
- Acronym / sponsor ID
- REVIVE / REVIVE
- Conditions
- Cervical Cancer Screening, HPV Vaccination
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
Key inclusion criteria (2 listed)
- Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
- Diagnosis established between 2019 and 2024.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the effectiveness of current Human Papillomavirus (HPV) vaccination and screening programs in reducing cervical cancer incidence in Spain.Data will be collected from existing medical records and supplemented with a specific questionnaire administered to the participating patients. | Biological | – |
Primary outcome
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.
3 secondary outcomes
Percentage of HPV vaccination and screening coverage by region and demographic factors
Time frame: 2019-2024
Association between misinformation and socioeconomic factors and the rate of HPV vaccination and screening
Time frame: 2019-2024
Reported frequency and nature of barriers to accessing to HPV vaccination and cervical cancer screening
Time frame: 2019-2014
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Screening and HPV Vaccination, run by Clinica Universidad de Navarra, Universidad de Navarra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HPV vaccination and cervical cancer screening among patients diagnosed with cervical cancer in Spain (time frame: 2019-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.