Imiquimod Treatment of High-grade CIN

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-12-31

Brief Summary

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

This multi-center, open-label, non-randomized controlled intervention study aims to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent side-effects associated with surgical treatment, such as premature birth in subsequent pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN will be adequately treated with imiquimod.

120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:

1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.
2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.

Related Clinical Trials

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

Imiquimod Treatment of CIN Lesions

NCT02329171

Cervical Intraepithelial Neoplasia

TERMINATED PHASE3

Imiquimod Treatment of Residual or Recurrent CIN Lesions: a Study Protocol

NCT02669459

Cervical Intraepithelial Neoplasia

UNKNOWN PHASE3

Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

NCT05405270

Cervical High Grade Squamous Intraepithelial Lesion Cervical Intraepithelial Neoplasia Grade 2/3 CIN 2/3 +1 more

RECRUITING

Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

NCT00031759

Cervical Cancer Precancerous Condition

COMPLETED PHASE2

Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

NCT02130323

Cervical Intraepithelial Neoplasia

COMPLETED PHASE2/PHASE3

Detailed Description

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

Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer. The standard treatment of histologically confirmed CIN2-3 is surgical excision by large loop excision of the transformation zone (LLETZ). This procedure has potential complications, such as hemorrhage, infection and preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed. Imiquimod cream has been studied as a non-invasive treatment alternative in high-grade CIN, but evidence on treatment efficacy is limited and evidence on disease recurrence and quality of life during and after treatment is lacking. One RCT has been performed and shows that treatment of high-grade CIN with vaginal imiquimod cream leads to disease regression in 73%. Side-effects were generally mild, but common. A recent survey among gynecologists and a patient preference study indicate that imiquimod treatment of high-grade CIN is mainly preferred by a selected population of women with a future pregnancy wish. These women accept a lower treatment efficacy and higher rates of side-effects from imiquimod treatment in order to prevent future preterm birth caused by LLETZ treatment. Ideally, those women with a high probability of successful treatment would be selected.

The objective of this study is to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions in a selected population of patients who prefer imiquimod treatment instead of LLETZ. The study also aims to identify predictive biomarkers clinical response to imiquimod treatment, in order to select patients in which good treatment response is expected.

The study design is a multicenter, open-label, non-randomized controlled intervention study. 120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:

1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.
2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.

A control colposcopy will be performed after 10 weeks for the imiquimod group. In case of progressive disease, the treatment will be ended and LLETZ will be performed as treatment. For patients in which the treatment is continued, treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies. Statistical analysis will be performed based on an intention-to-treat analysis.

The primary study endpoints are:

* Treatment efficacy of imiquimod and LLETZ treatment, defined as regression to CIN1 or less after 20 weeks for imiquimod and no need for additional therapy within 6 months for LLETZ treatment.
* Identification of predictive biomarkers for the efficacy of imiquimod treatment in the individual patient, based on biomarkers reflecting host, virus and cellular factors.

Secondary study endpoints are:

* Side effects of imiquimod therapy and LLETZ therapy.
* Disease recurrence at 6, 12 and 24 months follow-up.
* Quality of life (QoL) before, during and after treatment.

Conditions

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

Cervical Intraepithelial Neoplasia

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Imiquimod treatment arm

Treatment by vaginal imiquimod cream during 16 weeks.

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

Patients in this group are treated with vaginal imiquimod cream during 16 weeks. A control colposcopy with diagnostic biopsies will be performed after 10 weeks to rule out disease progression. A final colposcopy with diagnostic biopsies will be performed after 20 weeks to evaluate disease efficacy.

Standard treatment arm

Treatment by large loop excision of the transformation zone.

Group Type ACTIVE_COMPARATOR

Large Loop Excision of the Transformation Zone

Intervention Type PROCEDURE

Patients in this group are treated with LLETZ.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Imiquimod

Patients in this group are treated with vaginal imiquimod cream during 16 weeks. A control colposcopy with diagnostic biopsies will be performed after 10 weeks to rule out disease progression. A final colposcopy with diagnostic biopsies will be performed after 20 weeks to evaluate disease efficacy.

Intervention Type DRUG

Large Loop Excision of the Transformation Zone

Patients in this group are treated with LLETZ.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
* age of 18 years or older

Exclusion Criteria

* previous histologically confirmed high-grade CIN (CIN 2-3)
* concomitant vulvar and/or vaginal intraepithelial neoplasia
* previous cervical malignancy
* current malignant disease
* immunodeficiency (including HIV/AIDS and immunodepressive medication)
* pregnancy or lactation
* legal incapability

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No