Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356012
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-04
Brief Title:
Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated With Imiquimod
Sponsor:
Barretos Cancer Hospital
Organization:
Barretos Cancer Hospital
Study Overview
Official Title:
Immunophenotyping Microbiome Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients With High-grade Cervical Intraepithelial Lesions Treated With Imiquimod
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod Participants will be divided in 3 groups CIN 3 who will use 16 doses of imiquimod in the uterine cervix applied twice a week and will be treated with LEEP procedure 2 patients with CIN 3 who will undergo standard treatment with LEEP procedure 3 patients with negative cytology and HPV human papillomavirus test Blood and cervicovaginal lavage collections will be performed at different times for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients
Detailed Description:
INTRODUCTION High-grade intraepithelial lesions CIN 23 are considered precursor lesions of cervical cancer and its treatment involves destructive or excisional methods Some studies have proven the efficacy of the immunomodulator imiquimod as a topical treatment for CIN 23 lesions Imiquimod activates the innate immune response through dendritic cells monocytes and macrophages in addition to modulating the response pattern of T lymphocytes Thus the characterization of the immune response in the treatment with imiquimod in lesions caused by oncogenic HPV may benefit women in a way that it is possible to measure the response of each patient improving the understanding of its mechanism of action directly impacting the efficacy and adverse events caused by the drug OBJECTIVES To identify the immunophenotypic profile of the local immune response the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod MATERIALS AND METHODS It will be included 90 patients 60 with high-risk HPV diagnosed with CIN 3 and 30 patients with negative cytology and HPV Patients will be divided into 3 groups 1 patients with CIN 3 who will use 16 doses of imiquimod in the uterine cervix applied twice a week 2 patients with CIN 3 who will undergo standard treatment with Transformation Zone Excision EZT 3 patients with negative cytology and HPV Blood and cervicovaginal lavage will be collected for immunophenotypic analysis flow cytometry quantification of immunological mediators Cytometric Bead Array and evaluation of the microbiome MiniION The results obtained will be correlated with the clinical and pathological data of the patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None