Cervical CancerCIN3+plusNCT02323997
Human Papillomavirus in Cervical Cancer and Pre-cancer in Switzerland: The CIN3+Plus Study
An observational study of Cervical Cancer, run by University of Bern at 10 sites in Switzerland.
Trial summary
This study will investigate the types of HPV in samples from women with cervical pre-cancer and cancer and gather information to help investigate the impact of HPV vaccination in Switzerland. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 767 participants
- Where
- 10 sitesSwitzerland
- Study dates
- Jan 2015to May 2016
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with histologically confirmed CIN3+ lesions
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Participant is literate in German, French, Italian or English.
- Female, aged 18 years or above.
- Histologically confirmed CIN3+ lesions, i.e. CIN3, adenocarcinoma in situ and invasive carcinoma of the cervix.
- Participant resides in the canton Zurich, Geneva, Basel, Baselland, Luzern or Ticino.
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Switzerland10 sites
Viollier AG
Allschwil, Basel-Landschaft, 4123
Universitätsspital Basel
Basel
Viollier Weintraub SA
Geneva, 1206
HUG - Hôpitaux Universitaires de Genève
Geneva
Kantonsspital Baselland
Liestal
Istituto cantonale di patologia
Locarno
Kantonsspital Luzern
Lucerne
Institute of Pathology Enge
Zurich, 8002
Institut für klinische Pathologie Medica
Zurich, 8024
Universitätsspital Zürich
Zurich
About this study
Official title: Human Papillomavirus-Associated Cervical Neoplasia in Switzerland at the Start of a National Vaccination Programme: Crosssectional Study
This study will investigate the types of HPV in samples from women with cervical pre-cancer and cancer and gather information to help investigate the impact of HPV vaccination in Switzerland.
- Conditions
- Cervical Cancer
- Keywords
- HPV, cervical cancer, human papillomavirus, cervical pre-cancer, cervical neoplasia
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Human papillomavirus presence and type
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Office of Public Health, Switzerland
- Responsible party
- Sponsor
- Investigators
- Nicola Low, Principal investigator, University of Bern, Institute of Social and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323997
- Sponsor's protocol ID
- CIN3+plus
- Acronym
- CIN3+plus
- Status last verified
- Jul 2019
- First submitted
- 18 Dec 2014
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Egli-Gany D, Spaar Zographos A, Diebold J, Masserey Spicher V, Frey Tirri B, Heusser R, Dillner J, Petignat P, Sahli R, Low N; CIN3+plus study group. Human papillomavirus genotype distribution and socio-behavioural characteristics in women with cervical pre-cancer and cancer at the start of a human papillomavirus vaccination programme: the CIN3+ plus study. BMC Cancer. 2019 Jan 30;19(1):111. doi: 10.1186/s12885-018-5248-y.
PubMed 30700274
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus-Associated Cervical Neoplasia in Switzerland at the Start of a National Vaccination Programme: Crosssectional Study
- ClinicalTrials.gov ID
- NCT02323997
- Acronym / sponsor ID
- CIN3+plus / CIN3+plus
- Conditions
- Cervical Cancer
- Keywords
- HPV, cervical cancer, human papillomavirus, cervical pre-cancer, cervical neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Federal Office of Public Health, Switzerland
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Dec 2014 (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.
This study will investigate the types of HPV in samples from women with cervical pre-cancer and cancer and gather information to help investigate the impact of HPV vaccination in Switzerland.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with histologically confirmed CIN3+ lesions
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Participant is literate in German, French, Italian or English.
- Female, aged 18 years or above.
- Histologically confirmed CIN3+ lesions, i.e. CIN3, adenocarcinoma in situ and invasive carcinoma of the cervix.
- Participant resides in the canton Zurich, Geneva, Basel, Baselland, Luzern or Ticino.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Human papillomavirus presence and type
Time frame: 2 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 16 Jul 2019.
- Results publication: PubMed 30700274Egli-Gany D, Spaar Zographos A, Diebold J, Masserey Spicher V, Frey Tirri B, Heusser R, Dillner J, Petignat P, Sahli R, Low N; CIN3+plus study group. Human papillomavirus genotype distribution and socio-behavioural characteristics in women with cervical pre-cancer and cancer at the start of a human papillomavirus vaccination programme: the CIN3+ plus study. BMC Cancer. 2019 Jan 30;19(1):111. doi: 10.1186/s12885-018-5248-y.
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.
Nicola Low principal investigator
University of Bern, Institute of Social and Preventive Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by University of Bern at 10 sites in Switzerland.
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 5 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. 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.
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?
Human papillomavirus presence and type (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323997, which also lists 1 linked publication.
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 16 Jul 2019.