Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-07

Study Completion Date

2017-09-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PApillomavirus in REnal Transplant Patient

NCT02845739

Papillomavirus Infections

COMPLETED NA

Genital HPV Infections Before and After Renal Transplantation

NCT01717443

Human Papillomavirus Infections

COMPLETED

Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease

NCT03100682

Paediatric Kidney or Liver Transplantation Chronic Kidney Disease

UNKNOWN

Prophylactic Photodynamic Therapy to Organ Transplant Patients

NCT00365521

Organ Transplants

UNKNOWN NA

Herpes Virus Infections in Kidney Transplant Patients

NCT05604911

Kidney Transplant; Complications Varicella Zoster Virus Infection Vaccine-Preventable Diseases

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anogenital Dysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case group

250 Renal Transplant Recipients; 125 women and 125 men

No interventions assigned to this group

Control group

250 healthy controls; 125 women and 125 men

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Case group:

1. Renal transplant recipients men and women ≥ 18 years of age
2. ≥ 6 months posttransplantation
3. Stabile immunosuppressive regime
4. 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

Exclusion Criteria

* Case group:

1. Other known immunosuppression

Both case- og control group:
2. Previous HPV vaccination
3. Previous total hysterectomy
4. Inflammatory bowel disease
5. HIV infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes