HPV-test, Cervical Cancer and Follow-up

April 11, 2017 updated by: University of Aarhus

Recurrence After Surgery for Cervical Cancer - an Evaluation of the Follow-up Program.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients treated for cervical cancer.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Ajuvant oncologic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Human Papilloma Virus test

Patients treated with surgery alone for uterine cervical neoplasms attending surveillance at Dept. of Obstetrics and Gynecology, Oncogynecological unit, Aarhus University Hospital from 01.01.14 From 01.01.15 patients will be recruited from Oncogynecologic units at Aalborg University Hospital and Rigshospitalet. Recruitment of patients from these institutions has not been successful and has been closed.

It is expected due to political decisions that the cervical cancer patients from the uptake area of Aalborg University Hospital will be treated at Aarhus University Hospital and they will then be eligible for the study
Procedure: Human Papilloma Virus test from the vaginal vault
Surveillance after surgical treatment of early stage cervical cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of HPV Genotypes in Vagina (Type 16, 18 and Other)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
HPV Clearance From Vagina in Between the Two Planned Follow-up Visits.
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Time Frame
Evaluate 1-year, 2-year and 5-year Recurrence
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Katrine Fuglsang, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Follow-up
  • 1-10-72-323-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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