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Human Papillomavirus in Cervical Cancer and Pre-cancer in Switzerland: The CIN3+Plus Study (CIN3+plus)

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ClinicalTrials.gov Identifier: NCT02323997
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Swiss Federal Office of Public Health
Information provided by (Responsible Party):
University of Bern

Brief 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.

Condition or disease
Cervical Cancer

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Study Type : Observational
Actual Enrollment : 767 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Human Papillomavirus‐Associated Cervical Neoplasia in Switzerland at the Start of a National Vaccination Programme: Crosssectional Study
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer




Primary Outcome Measures :
  1. Human papillomavirus presence and type [ Time Frame: 2 years ]

Biospecimen Description:
Histologically confirmed CIN3+ lesions, i.e. CIN3, adenocarcinoma in situ and invasive carcinoma of the cervix.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with histologically confirmed CIN3+ lesions
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323997


Locations
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Switzerland
Viollier AG
Allschwil, Baselland, Switzerland, 4123
Universitätsspital Basel
Basel, Switzerland
Viollier Weintraub SA
Geneva, Switzerland, 1206
HUG ‐ Hôpitaux Universitaires de Genève
Geneva, Switzerland
Kantonsspital Baselland
Liestal, Switzerland
Istituto cantonale di patologia
Locarno, Switzerland
Kantonsspital Luzern
Luzern, Switzerland
Institute of Pathology Enge
Zurich, Switzerland, 8002
Institut für klinische Pathologie Medica
Zurich, Switzerland, 8024
Universitätsspital Zürich
Zürich, Switzerland
Sponsors and Collaborators
University of Bern
Swiss Federal Office of Public Health
Investigators
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Principal Investigator: Nicola Low University of Bern, Institute of Social and Preventive Medicine

Publications of Results:
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02323997     History of Changes
Other Study ID Numbers: CIN3+plus
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Keywords provided by University of Bern:
HPV
cervical cancer
human papillomavirus
cervical pre-cancer
cervical neoplasia
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female