Risk of cervical cancer among women who took an HPV test in 1990-1992, a 30-year follow-up study
| ISRCTN | ISRCTN10836802 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10836802 |
| Secondary identifying numbers | 2011/2397/REK Nord |
- Submission date
- 14/12/2020
- Registration date
- 23/12/2020
- Last edited
- 24/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Almost all cases of cervical cancer are caused by Human Papilloma Virus (HPV). HPV is a very common virus that can be passed on through any type of sexual contact with a man or a woman. There are more than 100 types of HPV, many of which are harmless. But some types can cause abnormal changes to the cells of the cervix, which can eventually lead to cervical cancer.
Cancer of the cervix ranks fourth of cancer types for both incidence and mortality among women worldwide. Long-term follow-up of patients with positive tests for HPV is insufficiently studied. The study objective was to compare HPV status at baseline with the risk of CIN3+ in the follow-up period of 30 years.
Who can participate?
All women referred to the HPV outpatient clinic at the University Hospital of Northern Norway (UNN) in 1990-1992, with an HPV test at baseline, were included in this retrospective cohort.
What does the study involve?
The study involves HPV-results from 1990-1992, using a two-step nonradioactive DNA hybridization method (ONCOR). In addition, a polymerase chain reaction (PCR) method using papilloma consensus primers was performed. Biopsy-verified CIN3+ was detected during follow up.
What are the possible benefits and risk of participating?
Participants may benefit from the possible detection of HPV which makes it possible to follow-up and treat precancer before the development of cervical cancer. No additional risks are anticipated.
Where is the study run from?
The University Hospital of Northern Norway.
When is the study starting and how long is it expected to run for?
October 2018 to December 2020. HPV testing was done in August 1990 to December 1992.
Who is funding the study?
This research was supported by the University Hospital of North Norway (http://www.unn.no/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Who is the main contact?
Dr Sveinung Wergeland Sorbye, sveinung.sorbye@unn.no
Contact information
Scientific
Department of Clinical Pathology
University Hospital of North Norway
Box 46
Tromso
9038
Norway
 ORCID ID |
0000-0002-8250-3992 |
|---|---|
| Phone | +47 77627223 |
| sveinung.sorbye@unn.no |
Study information
| Study design | Retrospective cohort comparing HR-HPV positive and HR-HPV negative regarding the risk of CIN3+ during 30 years of follow up |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available (retrospective study) |
| Scientific title | Long-term follow-up of patients with positive tests for HPV in 1990-1992, comparing HPV status at baseline with the risk of cervical intraepithelial neoplasia grade 3 or higher (CIN3+) in the follow-up period of 30 years |
| Study acronym | LTFU 30 |
| Study hypothesis | Women with positive HR-HPV test have a higher long-term risk of CIN3+ compared to HR-HPV negative women. |
| Ethics approval(s) | Approved 06/12/2011, The Regional Committee for Medical and Health Research Ethics, North Norway (REK North, iT The Arctic University of Norway, Box 6050 Langnes, 9037 Tromso, Norway; +47 776 46 140; rek-nord@fagmed.uit.no), ref: 2011/2397/REK Nord |
| Condition | Investigating the risk of CIN3+ in patients with an HPV test at UNN in 1990-1992 |
| Intervention | Observational trial: an exposed cohort consisting of women with a positive HR-HPV test (N=223) was compared to a control cohort consisting of women with a negative HR-HPV test (N=419). During the period of follow-up, we detected all incidents of CIN3+ within our study population, comparing HPV status at baseline with the incidence of CIN3+. |
| Intervention type | Other |
| Primary outcome measure | Detection of cervical cancer during follow up period, measured by biopsy and recorded in patient records |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/10/2018 |
| Overall study end date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 642 |
| Total final enrolment | 642 |
| Participant inclusion criteria | All women referred to the HPV outpatient clinic at the University Hospital of Northern Norway (UNN) in 1990-1992, with an HPV test at baseline |
| Participant exclusion criteria | History of medical or surgical treatment for cervical cancer. |
| Recruitment start date | 18/08/1990 |
| Recruitment end date | 31/12/1992 |
Locations
Countries of recruitment
- Norway
Study participating centre
Tromsø
9038
Norway
Sponsor information
Hospital/treatment centre
Sykehusveien 38
Tromsø
9019
Norway
| Phone | +47 77626000 |
|---|---|
| postmottak@helse-nord.no | |
| Website | http://www.unn.no/?lang=en_US |
"ROR" |
https://ror.org/030v5kp38 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- University Hospital of North Norway
- Location
- Norway
Results and Publications
| Intention to publish date | 01/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/06/2021 | 24/06/2021 | Yes | No |
Editorial Notes
24/06/2021: Publication reference added.
23/12/2020: Trial’s existence confirmed by Regional Committee for Medical and Health Research Ethics, North Norway.
