Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272240
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-14
Brief Title:
Tumor Microenvironment in Ovarian Cancer
Sponsor:
University of Udine
Organization:
University of Udine
Study Overview
Official Title:
Study of the Role of the Tumor Microenvironment in Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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:
MICO
Brief Summary:
A detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies The new frontier in biomedical research is represented by organoids a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy With this research project we expect to generate ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells immune cells and resident microbiota intratumoral bacteria andor microbial-derived molecules
Detailed Description:
Background Proved the importance of microenviroment in the onset and progression of ovarian cancer a detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies
Primary Objective The new frontier in biomedical research is represented by organoids a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy
Study Hypothesis To generate of ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells immune cells and resident microbiota intratumoral bacteria andor microbial-derived molecules
Trial Design Patients with primary diagnosis of epithelial ovarian cancer EOC stage III and IV according to FIGO referred to the Obstetrics-Gynecology Department of ASUFC for surgical removal will be selected It is expected that organoids will be cultured from 50 patients over the course of 3 years obtained by removed tissue from which pathologist will collect a fragment of tumor tissue and one from adjacent normal tissue as a healthy control From tumor tissue they will extract three different fragments one for the identification of cells composing the Tumor Microenvironment TME through single-cell analysis one for microbiome analysis and one for organoid generation to be conducted at the laboratories of the Department of Medical Area
InclusionExclusion Criteria Patients with a diagnosis of EOC will be considered eligible if they meet these criteria Age 18 years - 80 years serous ovarian carcinoma and FIGO Stage IIIIV EOC They will be excluded in case of ongoing or suspended immunosuppressive therapy within the last 6 months congenital or acquired immunodeficiency immunosuppressive state administration of chemotherapy for another neoplasm in the past 12 months non-epithelial ovarian tumors patients not undergoing surgical intervention BMI higher than 30 absence of Informed Consent
Primary Endpoint With this research project we expect to understand if it is also possible to stratify ovarian cancer patients based on the activation of AhR in cells of the Tumor Microenvironment TME including tumor cells and immune cells
Primary Objective The new frontier in biomedical research is represented by organoids a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy
Study Hypothesis To generate of ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells immune cells and resident microbiota intratumoral bacteria andor microbial-derived molecules
Trial Design Patients with primary diagnosis of epithelial ovarian cancer EOC stage III and IV according to FIGO referred to the Obstetrics-Gynecology Department of ASUFC for surgical removal will be selected It is expected that organoids will be cultured from 50 patients over the course of 3 years obtained by removed tissue from which pathologist will collect a fragment of tumor tissue and one from adjacent normal tissue as a healthy control From tumor tissue they will extract three different fragments one for the identification of cells composing the Tumor Microenvironment TME through single-cell analysis one for microbiome analysis and one for organoid generation to be conducted at the laboratories of the Department of Medical Area
InclusionExclusion Criteria Patients with a diagnosis of EOC will be considered eligible if they meet these criteria Age 18 years - 80 years serous ovarian carcinoma and FIGO Stage IIIIV EOC They will be excluded in case of ongoing or suspended immunosuppressive therapy within the last 6 months congenital or acquired immunodeficiency immunosuppressive state administration of chemotherapy for another neoplasm in the past 12 months non-epithelial ovarian tumors patients not undergoing surgical intervention BMI higher than 30 absence of Informed Consent
Primary Endpoint With this research project we expect to understand if it is also possible to stratify ovarian cancer patients based on the activation of AhR in cells of the Tumor Microenvironment TME including tumor cells and immune cells
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?:
None
Is an FDA AA801 Violation?:
None