NCT05405270 Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
| NCT ID | NCT05405270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Catharina Ziekenhuis Eindhoven |
| Condition | Cervical High Grade Squamous Intraepithelial Lesion |
| Study Type | OBSERVATIONAL |
| Enrollment | 410 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 410 participants in total. It began in 2022-06-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 response to imiquimod occurs in 55-73% of patients, however side-effects of imiquimod are common and can be extensive. Therefore, biomarkers which can predict response to imiquimod therapy are warranted, to increase therapy efficacy and to avoid side effects in patients who will not respond. This prospective, multi-center cohort study aims to validate the potential of immune related biomarkers to predict the clinical response of patients with primary cHSIL to imiquimod, aims to explore the value of these immune biomarkers in recurrent/residual cHSIL to predict treatment responses for imiquimod and aims to explore their potential in spontaneous regression of cHSIL (CIN2).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Edith Van Esch, MD, PhD
PRINCIPAL INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Frequently Asked Questions
Who can join the NCT05405270 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical High Grade Squamous Intraepithelial Lesion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05405270 currently recruiting?
Yes, NCT05405270 is actively recruiting participants. Contact the research team at predict-topic@catharinaziekenhuis.nl for enrollment information.
Where is the NCT05405270 trial being conducted?
This trial is being conducted at Breda, Netherlands, Dordrecht, Netherlands, Eindhoven, Netherlands, Hilversum, Netherlands and 11 additional locations.
Who is sponsoring the NCT05405270 clinical trial?
NCT05405270 is sponsored by Catharina Ziekenhuis Eindhoven. The principal investigator is Edith Van Esch, MD, PhD at Catharina Ziekenhuis Eindhoven. The trial plans to enroll 410 participants.