Anogenital DysplasiaNCT03018327
Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients
An observational study of Anogenital Dysplasia, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Transplant-related malignancies have emerged as one of the important complications after organ transplantation. Some studies have shown that transplant recipients have an increased risk of developing cancer, especially non-melanoma skin cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anogenital Dysplasia
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jan 2016to 6 Sep 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will include 250 male and female renal transplant recipients in the case group. The patients will be recruited from "The Transplantation Clinic" at the Department of Dermato-venereology, Bispebjerg Hospital (BBH), where they are being followed for development of cutaneous (pre-)malignancies and from the Department of Nephrology at Rigshospital and Herlev Hospital, Denmark. In the control group we will include 250 immunocompetent individuals consisting of male and female patients coming for control of birthmarks at the Nevus Clinic or Non-melanoma skin cancer and precancer at BBH and patients having laser treatment for benign cutaneous lesions at BBH. The participants will be enrolled in the study after informed consent has been obtained.
Who may be able to join
- -
- Case group:
- Renal transplant recipients men and women ≥ 18 years of age
- ≥ 6 months posttransplantation
- Stabile immunosuppressive regime
- No signs of acute rejection og the transplant
- Control group:
- 1. Health men and women ≥18years of age from the Nevus clinic, Laser clinic and non-melanoma skin cancer clinic, Bispebjerg Hospital, Copenhagen
Who cannot join
- Case group:
- Other known immunosuppression
- Both case- og control group:
- Previous HPV vaccination
- Previous total hysterectomy
- Inflammatory bowel disease
- HIV infection
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermato-venereology, Bispebjerg Hospital
Copenhagen, 2100
About this study
Official title: Ano-genital Human Papillomavirus (HPV) Infection, Genital Warts, Precancerous Lesions and Cancer Among Danish Renal Transplant Recipients
Transplant-related malignancies have emerged as one of the important complications after organ transplantation. Some studies have shown that transplant recipients have an increased risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic immunosuppression in these patients, there is an increasing focus on human papillomavirus (HPV) related cancers.
The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical precancerous lesions among RTRs.
Read more
Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal transplant recipients, together with identification of factors that play a role for development of anal and cervical precancerous lesions, is important for the possibility of early detection and treatment to prevent progression to ano-genital cancers. Cervical cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN), whereas high-resolution anoscopy is a newer modality for the detection of anal intra-epithelial neoplasia (AIN). International guidelines recommend annually screening against cervical cancer for female renal transplant recipients, but currently no recommendation exists on screening against anal cancer.
Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal transplant recipients and an immunocompetent control group. Furthermore to identify factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.
- Conditions
- Anogenital Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | 250 Renal Transplant Recipients; 125 women and 125 men | |
| Control group | 250 healthy controls; 125 women and 125 men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ano-genital HPV infection, dysplasia and warts
Prevalence of oral, penile, cervical and anal HPV infection, ano-genital dysplasia and warts
Measured: 18 month
Secondary outcomes (1)
Risk factors for the development of ano-genital dysplasia and warts
Identifying factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start7 Jan 2016
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anogenital DysplasiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Helle Kiellberg Larsen, Bispebjerg Hospital
- Investigators
- Helle Kiellberg Larsen, MD, Principal investigator, Department of Dermato-venereology, Bispebjerg Hospital, 2400 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018327
- Sponsor's protocol ID
- H-15014510
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsen HK, Kjaer SK, Haedersdal M, Kjaer AK, Bonde JH, Sorensen SS, Thomsen LT. Anal Human Papillomavirus Infection in Kidney Transplant Recipients Compared With Immunocompetent Controls. Clin Infect Dis. 2022 Nov 30;75(11):1993-1999. doi: 10.1093/cid/ciac285.
PubMed 35438132
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ano-genital Human Papillomavirus (HPV) Infection, Genital Warts, Precancerous Lesions and Cancer Among Danish Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT03018327
- Acronym / sponsor ID
- H-15014510
- Conditions
- Anogenital Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 7 Jan 2016
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 12 Jan 2017 (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.
Transplant-related malignancies have emerged as one of the important complications after organ transplantation. Some studies have shown that transplant recipients have an increased risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic immunosuppression in these patients, there is an increasing focus on human papillomavirus (HPV) related cancers.
The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical precancerous lesions among RTRs.
Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal transplant recipients, together with identification of factors that play a role for development of anal and cervical precancerous lesions, is important for the possibility of early detection and treatment to prevent progression to ano-genital cancers. Cervical cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN), whereas high-resolution anoscopy is a newer modality for the detection of anal intra-epithelial neoplasia (AIN). International guidelines recommend annually screening against cervical cancer for female renal transplant recipients, but currently no recommendation exists on screening against anal cancer.
Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal transplant recipients and an immunocompetent control group. Furthermore to identify factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –250 Renal Transplant Recipients; 125 women and 125 men |
| Control group | – | –250 healthy controls; 125 women and 125 men |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will include 250 male and female renal transplant recipients in the case group. The patients will be recruited from "The Transplantation Clinic" at the Department of Dermato-venereology, Bispebjerg Hospital (BBH), where they are being followed for development of cutaneous (pre-)malignancies and from the Department of Nephrology at Rigshospital and Herlev Hospital, Denmark. In the control group we will include 250 immunocompetent individuals consisting of male and female patients coming for control of birthmarks at the Nevus Clinic or Non-melanoma skin cancer and precancer at BBH and patients having laser treatment for benign cutaneous lesions at BBH. The participants will be enrolled in the study after informed consent has been obtained.
Key inclusion criteria (8 listed)
- -
- Renal transplant recipients men and women ≥ 18 years of age
- ≥ 6 months posttransplantation
- Stabile immunosuppressive regime
- No signs of acute rejection og the transplant
Key exclusion criteria (7 listed)
- Case group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of ano-genital HPV infection, dysplasia and warts
Time frame: 18 month
Prevalence of oral, penile, cervical and anal HPV infection, ano-genital dysplasia and warts
1 secondary outcome
Risk factors for the development of ano-genital dysplasia and warts
Time frame: 18 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Derived from this study: PubMed 35438132Larsen HK, Kjaer SK, Haedersdal M, Kjaer AK, Bonde JH, Sorensen SS, Thomsen LT. Anal Human Papillomavirus Infection in Kidney Transplant Recipients Compared With Immunocompetent Controls. Clin Infect Dis. 2022 Nov 30;75(11):1993-1999. doi: 10.1093/cid/ciac285.
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.
Helle Kiellberg Larsen, MD principal investigator
Department of Dermato-venereology, Bispebjerg Hospital, 2400 Copenhagen, Denmark
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 Anogenital Dysplasia, run by Bispebjerg Hospital 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 19 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ano-genital HPV infection, dysplasia and warts (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03018327, which also lists 1 linked publication.
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 19 Jan 2018.