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A Retrospective Epidemiological Study of Natural History of HPV Infections in Women Aged 18 Years and Above With Recurrent Conization Following a Primary Conization for High Grade Lesions/ Microinvasive Cervical Carcinomas, in Norway


N/A
18 Years
N/A
Not Enrolling
Female
Microinvasive Carcinomas and Invasive Cervical Cancer, High Grade Cervical Lesions

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Trial Information

A Retrospective Epidemiological Study of Natural History of HPV Infections in Women Aged 18 Years and Above With Recurrent Conization Following a Primary Conization for High Grade Lesions/ Microinvasive Cervical Carcinomas, in Norway


This protocol posting has been updated following Protocol Amendment 1 (02 April 2010). The
sections impacted are: enrolment, outcome measures and eligibility criteria.


Inclusion Criteria:



All subjects must meet the following criteria at study entry:

- Women aged 18 years and above at the time of the collection of the primary cone
specimen;

- Who have undergone for the first time a conization due to high grade lesions or
microinvasive cervical carcinomas, histologically diagnosed in 2003, with possible
extension backwards in time;

- Availability of recurrent cone specimen with high grade lesions/ microinvasive
cervical carcinomas or invasive cervical cancer;

- Availability in designated local laboratories of the primary and recurrent cone
specimens;

- The cone specimen was adequately preserved;

- Written informed consent obtained from the subject. If the subject is deceased, the
cone and biopsy specimens will be used according to prior approval from the Ethics
Committee.

Exclusion Criteria:

None.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.

Outcome Time Frame:

At the end of the study.

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Norway: Norwegian Medicines Agency

Study ID:

112674

NCT ID:

NCT00924794

Start Date:

June 2010

Completion Date:

August 2010

Related Keywords:

  • Microinvasive Carcinomas and Invasive Cervical Cancer
  • High Grade Cervical Lesions
  • Carcinoma
  • Uterine Cervical Neoplasms
  • Uterine Cervical Diseases

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