NCT02323997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
767

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

December 18, 2014

Last Update Submit

July 12, 2019

Conditions

Keywords

HPVcervical cancerhuman papillomaviruscervical pre-cancercervical neoplasia

Outcome Measures

Primary Outcomes (1)

  • Human papillomavirus presence and type

    2 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with histologically confirmed CIN3+ lesions

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Viollier AG

Allschwil, Basel-Landschaft, 4123, Switzerland

Location

Universitätsspital Basel

Basel, Switzerland

Location

Viollier Weintraub SA

Geneva, 1206, Switzerland

Location

HUG - Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Kantonsspital Baselland

Liestal, Switzerland

Location

Istituto cantonale di patologia

Locarno, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

Institute of Pathology Enge

Zurich, 8002, Switzerland

Location

Institut für klinische Pathologie Medica

Zurich, 8024, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

Biospecimen

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

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Nicola Low

    University of Bern, Institute of Social and Preventive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 24, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations