Clinical trial · Observational
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
NCT05405270CI-TRIAL-00069493PRedICT-TOPICrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical High Grade Squamous Intraepithelial Lesion | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2x vaginal swab for microbiome analysis | Diagnostic Test | — | UNRESOLVED |
| 3x vaginal swab for microbiome analysis | Diagnostic Test | — | UNRESOLVED |
| Expectative management | Other | — | UNRESOLVED |
| Imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Primary cHSIL
- description
- Women with a first diagnosis of cHSIL (e.g. CIN 2 or CIN 3) who prefer treatment with imiquimod.
- interventionNames
- Drug: Imiquimod
- Diagnostic Test: 3x vaginal swab for microbiome analysis
- label
- Recurrent/residual cHSIL (rrcHSIL)
- description
- Women who were treated for cHSIL before, but who have a residual or recurrent lesion and prefer treatment with imiquimod.
- interventionNames
- Drug: Imiquimod
- Diagnostic Test: 3x vaginal swab for microbiome analysis
- label
- CIN 2 observational group
- description
- Women with primary CIN 2 who prefer expectant management to await the potential of spontaneous regression.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDde Witte CJ, van de Sande AJ, van Beekhuizen HJ, Koeneman MM, Kruse AJ, Gerestein CG. Imiquimod in cervical, vaginal and vulvar intraepithelial neoplasia: a review. Gynecol Oncol. 2015 Nov;139(2):377-84. doi: 10.1016/j.ygyno.2015.08.018. Epub 2015 Aug 31. PMID 26335596
- BACKGROUNDLoopik DL, van Drongelen J, Bekkers RLM, Voorham QJM, Melchers WJG, Massuger LFAG, van Kemenade FJ, Siebers AG. Cervical intraepithelial neoplasia and the risk of spontaneous preterm birth: A Dutch population-based cohort study with 45,259 pregnancy outcomes. PLoS Med. 2021 Jun 4;18(6):e1003665. doi: 10.1371/journal.pmed.1003665. eCollection 2021 Jun. PMID 34086680
- BACKGROUNDHendriks N, Koeneman MM, van de Sande AJM, Penders CGJ, Piek JMJ, Kooreman LFS, van Kuijk SMJ, Hoosemans L, Sep SJS, de Vos Van Steenwijk PJ, van Beekhuizen HJ, Slangen BFM, Nijman HW, Kruitwagen RFPM, Kruse AJ. Topical Imiquimod Treatment of High-grade Cervical Intraepithelial Neoplasia (TOPIC-3): A Nonrandomized Multicenter Study. J Immunother. 2022 Apr 1;45(3):180-186. doi: 10.1097/CJI.0000000000000414. PMID 35180719
- BACKGROUNDAbdulrahman Z, de Miranda N, van Esch EMG, de Vos van Steenwijk PJ, Nijman HW, J P Welters M, van Poelgeest MIE, van der Burg SH. Pre-existing inflammatory immune microenvironment predicts the clinical response of vulvar high-grade squamous intraepithelial lesions to therapeutic HPV16 vaccination. J Immunother Cancer. 2020 Mar;8(1):e000563. doi: 10.1136/jitc-2020-000563. PMID 32169871
- BACKGROUNDAbdulrahman Z, de Miranda NFCC, Hellebrekers BWJ, de Vos van Steenwijk PJ, van Esch EMG, van der Burg SH, van Poelgeest MIE. A pre-existing coordinated inflammatory microenvironment is associated with complete response of vulvar high-grade squamous intraepithelial lesions to different forms of immunotherapy. Int J Cancer. 2020 Nov 15;147(10):2914-2923. doi: 10.1002/ijc.33168. Epub 2020 Jul 3. PMID 32574376
- BACKGROUNDGalon J, Bruni D. Approaches to treat immune hot, altered and cold tumours with combination immunotherapies. Nat Rev Drug Discov. 2019 Mar;18(3):197-218. doi: 10.1038/s41573-018-0007-y.