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ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

2014-07-23 21:13:54 | BioPortfolio

Summary

The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cervical Intraepithelial Neoplasia

Intervention

Topical imiquimod therapy

Location

Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology
Vienna
Austria
1090

Status

Recruiting

Source

Medical University of Vienna

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:54-0400

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Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia

This phase I clinical trial studies the side effects of topical fluorouracil and imiquimod ointment in treating patients with high-grade cervical intraepithelial neoplasia. Topical fluorou...

Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia

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

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Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

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PubMed Articles [10637 Associated PubMed Articles listed on BioPortfolio]

In situ expressions of protein 16 (p16) and transforming growth factor beta-1 in patients with cervical intraepithelial neoplasia and cervical cancer.

Protein 16 (p16) and transforming growth factor-beta 1 (TGF- β1) are important tumor suppressor molecules. The aim of this study was to evaluate the frequency and simultaneous expression of p16 and T...

Interaction between vaginal micro-environment alterations and HPV16 infection in cervical intraepithelial neoplasia.

To explore the effect of vaginal micro-environment alterations and HPV16 infection and their interaction in the progression of cervical intraepithelial neoplasia. The participants of this study came ...

Suppressive antiretroviral therapy associates with effective treatment of high-grade cervical intraepithelial neoplasia.

To assess if women living with HIV (WLWH) have poorer outcome after treatment of cervical intraepithelial neoplasia (CIN2+) than HIV-negative women and to identify predictors of CIN2+ treatment failur...

Treatment of HPV-associated Anal Lesions in HIV-positive Patients - Comparison of Surgical Treatment and Topical Therapy with Imiquimod.

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Factors affecting residual/recurrent cervical intraepithelial neoplasia after cervical conization with negative margins.

To identify factors for predicting residual or recurrent cervical intraepithelial neoplasia (CIN) after cervical conization with negative margins.

Medical and Biotech [MESH] Definitions

Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.

A malignancy arising in uterine cervical epithelium and confined thereto, representing a continuum of histological changes ranging from well-differentiated CIN 1 (formerly, mild dysplasia) to severe dysplasia/carcinoma in situ, CIN 3. The lesion arises at the squamocolumnar cell junction at the transformation zone of the endocervical canal, with a variable tendency to develop invasive epidermoid carcinoma, a tendency that is enhanced by concomitant human papillomaviral infection. (Segen, Dictionary of Modern Medicine, 1992)

A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.

A cytological test finding often from PAP SMEARS that shows abnormal lesions of SQUAMOUS EPITHELIAL CELLS of the CERVIX. It is a diagnostic criterion used in the Bethesda System for UTERINE CERVICAL NEOPLASMS and represents the PAP TEST result that is abnormal. Although squamous intraepithelial lesions test result does not mean UTERINE CERVICAL NEOPLASMS it requires follow-ups (e.g., HPV DNA TESTS; and COLPOSCOPY).

Therapy using oral or topical photosensitizing agents with subsequent exposure to light.

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