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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02096016
Other study ID # Follow-up
Secondary ID 1-10-72-323-13
Status Recruiting
Phase N/A
First received March 21, 2014
Last updated April 11, 2017
Start date January 2014
Est. completion date December 2019

Study information

Verified date April 2017
Source University of Aarhus
Contact Katrine Fuglsang, MD
Email katrine.fuglsang@ki.au.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators have planned this project to evaluate the follow-up program after surgery due to cervical cancer and to explore the possibilities for different tests of Human Papilloma Virus (HPV) in contributing to the customization of the follow-up program.

Purpose:

The investigators effort is to provide the background for an evidence-based update of the follow-up program after surgery due to cervical cancer with the purpose of early diagnosis of recurrence affecting quality of life for as few women as possible.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Surgery. FIGO stage IA-IB. > 18 years

Exclusion Criteria:

- Ajuvant oncologic treatment

Study Design


Intervention

Procedure:
Human Papilloma Virus test from the vaginal vault
Surveillance after surgical treatment of early stage cervical cancer

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluate 1-year, 2-year and 5-year Recurrence 5 years
Primary Prevalence of HPV Genotypes in Vagina (Type 16, 18 and Other) 2 years
Secondary HPV Clearance From Vagina in Between the Two Planned Follow-up Visits. 2 years
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