Clinical trial NCT06272240: Tumor Microenvironment in Ovarian Cancer
Official title: Study of the Role of the Tumor Microenvironment in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer Stage III
Ovarian Cancer Stage IV
Keywords: organoids,tumor microenviroment,ovarian cancer
Lead sponsor: University of Udine
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary diagnosis (t=0) of epithelial ovarian cancer (stage III and IV according to FIGO)

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 and/or 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 and/or 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.

Inclusion/Exclusion 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 III/IV 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Age \< 80 years
* Serous ovarian carcinoma
* FIGO Stage III-IV

Exclusion Criteria:

* 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 \> 30
* Absence of Informed Consent

Primary outcomes:
measure: • Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids
timeFrame: from enrollment to the end of follow up at 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Università degli Studi di Udine
state: UD
Study officials:
References:
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