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Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

Study acronym: PRedICT-TOPIC
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 11, 2023 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 13 to 15v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2022 to Jun 1, 2022
    • Site details revised at 13 of 13 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05405270
Lead Sponsor Catharina Ziekenhuis Eindhoven
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Stichting Olijf: Dutch patient association for women with gynaecological cancer, Leids Universitair Medisch Centrum: Department of Medical Oncology and Department of Pathology, Maastricht Universitair Medisch Centrum: Department of Gynaecology and Department of Pathology, Erasmus Medisch Centrum: Department of Gynaecology, Radboud Medisch Centrum: Department of Gynaecology
Conditions
(from sponsor)		 Cervical High Grade Squamous Intraepithelial Lesion, Cervical Intraepithelial Neoplasia Grade 2/3, CIN 2/3, Cervical Intraepithelial Neoplasia
Related terms Uterine Cervical Dysplasia
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov