Imiquimod for Cervical Intraepithelial Neoplasia

Recruiting · 18+ · Female · New Haven, CT

Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)

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About the trial for Cervical Intraepithelial Neoplasia

Eligible Conditions
Cervical Dysplasia · Cervical Intraepithelial Neoplasia · Uterine Cervical Dysplasia

Treatment Groups

This trial involves 2 different treatments. Imiquimod is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
9-valent HPV vaccine
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

First Studied
Drug Approval Stage
How many patients have taken this drug
9-valent HPV vaccine
Completed Phase 3
FDA approved


This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must be at least 18 years of age based on previous and current cervical cancer screening guidelines.
Patients must be fluent in speaking English or Spanish.
Patients must have untreated cervical biopsy-proven, CIN 2/3 ectocervical lesion(s).
Patients must have satisfactory colposcopy with visualization of the entire transformation zone or a negative endocervical curettage if colposcopy is unsatisfactory.
Patients must be high-risk HPV+ as determined by commercially available DNA hybridization test which tests for 13 high-risk HPV types.
All Patients must have a histologic diagnosis of CIN 2,3 cervical lesion(s) confirmed by a study pathologist within past 10 weeks.
Patients must have signed an approved informed consent.
Patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception.
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Odds of Eligibility
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Between weeks 20 and 24 (approximately week 22)
Screening: ~3 weeks
Treatment: Varies
Reporting: Between weeks 20 and 24 (approximately week 22)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Between weeks 20 and 24 (approximately week 22).
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Imiquimod will improve 1 primary outcome and 1 secondary outcome in patients with Cervical Intraepithelial Neoplasia. Measurement will happen over the course of Between weeks 20 and 24 (approximately week 22).

Incidence of HPV Clearance
HPV Clearance will be categorized as 'yes' or 'no' and the evaluations are the following criteria: HPV clearance will be measured by both the Roche cobas HPV Test utilized by pathology concomitant with the pap test at final study visit which assesses for presence of 14 high risk HPV types as well as HPV 16/18 genotyping performed by Santin Lab.
Incidence of Objective Response
The major parameters of objective response to be assessed include treatment efficacy defined as histologic regression of cervical dysplasia to CIN 1 or less after the end of imiquimod treatment, HPV clearance and treatment tolerance. Objective response will be categorized as 'yes' or 'no' and included in the evaluations are the following criteria: Histologic regression (HR): Histologic regression of all index lesions to CIN 1 or less after end of imiquimod treatment period. Histologic remission (HM): Complete regression of cervical dysplasia at all index biopsy sites after end of imiquimod treatment period. Persistent Disease (PR): One or more index lesions persists with CIN 2,3 high grade dysplasia or new lesions are identified colposcopically and histologically confirmed to be CIN 2,3. Progressive Disease (PD): Worsening histology of an index lesion.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can cervical intraepithelial neoplasia be cured?

There is an association between the presence of abnormal cervical cytology and the presence of high-grade cervical neoplasia. Patients whose premalignant cytology disappears after appropriate treatment have a low risk of high-grade cervical disease. With appropriate treatment, high-grade cervical intraepithelial neoplasia may vanish.

Anonymous Patient Answer

How many people get cervical intraepithelial neoplasia a year in the United States?

About 12,000,000 cervical intraepithelial neoplasia cases are diagnosed on a given year, of which approximately half are atrophic. Overall, women 30 years of age and older show the greatest increase.

Anonymous Patient Answer

What is cervical intraepithelial neoplasia?

This disorder may occur in women or men of any age group. Cervical intraepithelial neoplasia is graded from 0 to 3; grade 1 does not represent or lead to more dysplasia, or abnormal histopathology. However, if found on screening, and a high grade is suspected, then further assessment such as colposcopy should be offered in order to detect, and possibly treat, premalignant or malignant disease, if present, before it progresses to invasive carcinoma.

Anonymous Patient Answer

What are common treatments for cervical intraepithelial neoplasia?

A wide diversity of approaches is used for treatment of CIN 2 or 3. The most used approaches are surgery, especially for LSIL, followed by conization with abrasion and cryotherapy. Ablation is used mainly or wholly for HSIL.

Anonymous Patient Answer

What causes cervical intraepithelial neoplasia?

CIN usually develops from an underlying cervical transformation and is almost always caused by human papilloma virus. Most women with low grade CIN will clear the disease without treatment.

Anonymous Patient Answer

What are the signs of cervical intraepithelial neoplasia?

NCCL or CIN were detected in 70.9% of women. NCCL was detected in 9.1% in the second (2-4 years) of the three consecutive biopsies; while CIN was detected in 28.5% in the third (5-10 years) of the biopsies. CIN-2 was detected the most frequently (41.4% of women).

Anonymous Patient Answer

Who should consider clinical trials for cervical intraepithelial neoplasia?

The high sensitivity and specificity of digital video colposcopy in detecting CIN grades 2-3 in patients 35–65 years of age suggest that those patients with CIN of grade 3 could be candidates for a more intensive treatment schedule with followup cytology. Additional trials of digital colposcopy with excisional biopsy are still needed before conclusions can be drawn.

Anonymous Patient Answer

How does imiquimod work?

This in vitro study using multiple different dosage regimes demonstrated a significant reduction in proliferation, cell death, and migration in human primary cervical cancer cells. Based on in vitro findings, these results strongly suggest that imiquimod represents a new class of immune modulators (Immudex or Biovail) for clinical cervical cancer treatments in the future.

Anonymous Patient Answer

What is the primary cause of cervical intraepithelial neoplasia?

CIN is often caused by human papilloma virus (HPV), usually of low-risk HPV type. The main cause of CIN 3 that does not regress spontaneously is either high-risk HPV of any type or multiple types. CIN 2 and 1 are caused by low-risk HPV that is not viral.

Anonymous Patient Answer

What is the survival rate for cervical intraepithelial neoplasia?

(1) In patients with CIN 3 and CIN 4 biopsy findings, the 5-year survival rate is 50%. (2) In patients with CIN 2 biopsy results, the 5-year survival rate for CIN 3 and CIN 4 is 90%. (3) In patients with CIN 1 biopsy findings, the 5-year survival rate for CIN 3 and CIN 4 is 40%, and for CIN 1 is 31%. For patients diagnosed with HSIL, 5-year survival is 53%. The probability of progression to invasive squamous cell carcinoma is 18-40%.

Anonymous Patient Answer

Is imiquimod typically used in combination with any other treatments?

There were no statistically significant differences between the topical combinations studied. There were some significant changes in the occurrence of adverse events requiring treatment in each group, but the conclusions of the study do not allow definite conclusions about the risks and benefits of imiquimod+salicylic acid, imiquimod+metronidazole-aluminium hydroxide, imiquimod+salicylic-aluminium hydroxide, and imiquimod+aluminium hydroxide. It remained unknown whether topical and systemic treatment with imiquimod alters the natural history of HSIL in patients with high grade cervical intraepithelial neoplasia. The investigators recommend that treatment be determined by local practice.

Anonymous Patient Answer

Does imiquimod improve quality of life for those with cervical intraepithelial neoplasia?

Imiquimod improved quality of life in women with CIN. Additional research is needed to explore the mechanisms and to determine whether treatment-related quality improvements outweigh the discomfort associated with using a topical treatment in this group for CIN.

Anonymous Patient Answer
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