Human Papillomavirus in Cervical Cancer and Pre-cancer in... | NCT02323997

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

NCT02323997

Sponsor

University of Bern

Status

Completed

Last Update Posted

Jul 16, 2019Actual

Enrollment

767Actual

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Dec 18, 2014

First Submission Date that Met QC Criteria

Dec 18, 2014

First Posted Date

Dec 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2019

Last Update Posted Date

Jul 16, 2019Actual

Name	Class
Federal Office of Public Health, Switzerland	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

767Actual

Measure	Description	Time Frame
Human papillomavirus presence and type		2 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women with histologically confirmed CIN3+ lesions

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicola Low	University of Bern, Institute of Social and Preventive Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Viollier AG		Allschwil	Basel-Landschaft	4123	Switzerland
Universitätsspital Basel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30700274	Result	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.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site