Status:
RECRUITING
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Olijf: Dutch patient association for women with gynaecological cancer
Conditions:
Cervical High Grade Squamous Intraepithelial Lesion
Cervical Intraepithelial Neoplasia Grade 2/3
Eligibility:
FEMALE
18+ years
Brief Summary
Imiquimod is a good non-invasive treatment option for women with cervical high-grade squamous intraepithelial neoplasia (cHSIL), especially those with a possible (future) pregnancy wish. Complete resp...
Detailed Description
RATIONALE: A persistent high risk Human Papilloma Virus (hrHPV) infection can cause (pre)malignant anogenital lesions of the cervix, vulva or vagina. Cervical high grade squamous intraepithelial lesio...
Eligibility Criteria
Inclusion
- Primary cHSIL lesions (e.g. CIN3 or CIN 2), histologically confirmed by diagnostic biopsy Nota bene: In case of CIN 2, expectative management must be discussed according to the Dutch national guideline with the patient, if the patient prefers imiquimod therapy the patient can be treated with imiquimod and enrolled in the study, if the patient prefers expectative management they can be enrolled in the observational CIN 2 group.
- Recurrent or residual cHSIL lesions after initial LLETZ treatment (e.g. CIN2 or CIN3), histologically confirmed by diagnostic biopsy
- Age of 18 years or older
Exclusion
- Concomitant diagnoses of VAIN (vaginal intraepithelial neoplasia e.g. vaginal HSIL)
- PAP (Papanicolaou) 4 cytology as indication for the baseline colposcopy at study entrance
- Adenocarcinoma in situ (AIS) diagnosis
- Previous imiquimod therapy for cHSIL
- Previous cervical malignancy
- Current malignant disease
- Immunodeficiency (including HIV/AIDS and immunosuppressive medication)
- Pregnancy
- Legal incapability
- Insufficient knowledge of the Dutch language
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT05405270
Start Date
June 1 2022
End Date
December 1 2026
Last Update
September 11 2023
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Amphia
Breda, Netherlands
2
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
3
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
4
Tergooi MC
Hilversum, Netherlands