Human Papilloma VirusNCT02096016
HPV-test, Cervical Cancer and Follow-up
An observational study of Human Papilloma Virus and Uterine Cervical Neoplasms, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Papilloma Virus, Uterine Cervical Neoplasms, Recurrence
- What is being tested?
- Human Papilloma Virus test from the vaginal vault
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for cervical cancer.
Who may be able to join
- Surgery. FIGO stage IA-IB. > 18 years
Who cannot join
- Ajuvant oncologic treatment
Trial locations and contacts
1 site in 1 country.
Katrine Fuglsang, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Fuglsang, katrine.fuglsang@ki.au.dk
Fuglsang
About this study
Official title: 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.
- Being tested
- Human Papilloma Virus test from the vaginal vault
- Keywords
- Surveillance, Follow up
- Medical subject headings
- Uterine Cervical Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Papilloma Virus test from the vaginal vaultProcedure or surgery
Surveillance after surgical treatment of early stage cervical cancer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Human Papilloma Virus test from the vaginal vault |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HPV Genotypes in Vagina (Type 16, 18 and Other)
Measured: 2 years
Secondary outcomes (1)
HPV Clearance From Vagina in Between the Two Planned Follow-up Visits.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrine Fuglsang, MD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096016
- Sponsor's protocol ID
- Follow-up
- Other IDs
- 1-10-72-323-13
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2014
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence After Surgery for Cervical Cancer - an Evaluation of the Follow-up Program.
- ClinicalTrials.gov ID
- NCT02096016
- Acronym / sponsor ID
- Follow-up
- Keywords
- Surveillance, Follow up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Papilloma Virus test | – | Procedure: Human Papilloma Virus test from the vaginal vaultPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for cervical cancer.
Key inclusion criteria (1 listed)
- Surgery. FIGO stage IA-IB. > 18 years
Key exclusion criteria (1 listed)
- Ajuvant oncologic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Papilloma Virus test from the vaginal vaultSurveillance after surgical treatment of early stage cervical cancer | Procedure or surgery | Human Papilloma Virus test |
Primary outcome
Prevalence of HPV Genotypes in Vagina (Type 16, 18 and Other)
Time frame: 2 years
1 secondary outcome
HPV Clearance From Vagina in Between the Two Planned Follow-up Visits.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine Fuglsang, MD contact
Katrine Fuglsang, MD study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus and Uterine Cervical Neoplasms, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrine Fuglsang, MD (katrine.fuglsang@ki.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HPV Genotypes in Vagina (Type 16, 18 and Other) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.