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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

Clinical Trials [1602 Associated Clinical Trials listed on BioPortfolio]

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

RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate ...

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

This is a randomized Phase II, three arm control trial in patients with Cervical Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3 meeting eligibilit...

Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development of cancer. Applying topical imiquimod before abnormal cervical cells are removed may b...

Cyclophosphamide and IRX-2 in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3

This randomized phase II trial studies how well cyclophosphamide and IRX-2 work in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neop...

PubMed Articles [10568 Associated PubMed Articles listed on BioPortfolio]

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...

Risk for Cervical Intraepithelial Neoplasia Grade 3 or Higher in Follow-Up of Women With a Negative Cervical Biopsy.

The Norwegian Cervical Cancer Screening Programme recommends follow-up of histologically confirmed normal/cervical intraepithelial neoplasia (CIN) 1 with combined cytology and human papillomavirus tes...

Management of Early Cervical Stromal Invasion FIGO Stage 1A1 When Margins Are Involved With Cervical Intraepithelial Neoplasia.

Women with International Federation of Gynecology and Obstetrics stage 1A1 cervical carcinoma were evaluated to determine whether repeat excision for large loop excision transformation zone margins po...

Depth of Cervical Intraepithelial Neoplasia Grade 3 in Peruvian Women: Implications for Therapeutic Depth of Necrosis.

To determine the involvement of cervical intraepithelial neoplasia grade 3 (CIN3) in a population of women in a lower-resource setting.

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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