Cervical CancerPhase 4CoheaHr-WP4NCT02837926
Comparing Health Services Interventions for the Prevention of HPV-related Cancer
A Phase 4 study testing questionnaire, Gardasil vaccine and Cervarix® in people with Cervical Cancer, run by CHU de Reims at 1 site in France.
Trial summary
The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- questionnaire, Gardasil vaccine and Cervarix®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women within the age range of 25-45
- attending cervical cancer screening
Who cannot join
- previous history of HPV vaccine administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Work Package 4: HPV Vaccination of Women in Screening Ages
The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.
Read the detailed description
3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.
Safety data and HPV vaccine compliance will be assessed.
A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.
Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.
- Conditions
- Cervical Cancer
- Being tested
- questionnaire, Gardasil vaccine, Cervarix®
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Gardasil vaccineBiological
Cervarix®Biological
| Study group | Role | What they receive |
|---|---|---|
| women attending for cervical cancer screening | Experimental | Not described Receives: Other: questionnaire; Biological: Gardasil vaccine; Biological: Cervarix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of vaccinated patients
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837926
- Sponsor's protocol ID
- PO15019
- Acronym
- CoheaHr-WP4
- Status last verified
- Apr 2019
- First submitted
- 13 Jul 2016
- Last updated
- 10 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Package 4: HPV Vaccination of Women in Screening Ages
- ClinicalTrials.gov ID
- NCT02837926
- Acronym / sponsor ID
- CoheaHr-WP4 / PO15019
- Conditions
- Cervical Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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 study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.
Detailed description
3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.
Safety data and HPV vaccine compliance will be assessed.
A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.
Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women attending for cervical cancer screening | Experimental | Other: questionnaire, Biological: Gardasil vaccine, Biological: Cervarix® |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women within the age range of 25-45
- attending cervical cancer screening
Key exclusion criteria (1 listed)
- previous history of HPV vaccine administration
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 |
|---|---|---|
| questionnaire | Other | women attending for cervical cancer screening |
| Gardasil vaccine | Biological | women attending for cervical cancer screening |
| Cervarix® | Biological | women attending for cervical cancer screening |
Primary outcome
number of vaccinated patients
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing questionnaire, Gardasil vaccine and Cervarix® in people with Cervical Cancer, run by CHU de Reims at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of vaccinated patients (time frame: up to 3 years). 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 10 Apr 2019.