Study Results
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Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-01-02
2027-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Age \< 80 years
* Serous ovarian carcinoma
* FIGO Stage III-IV
Exclusion Criteria
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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University of Udine
OTHER
Responsible Party
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Locations
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Università degli Studi di Udine
Udine, UD, Italy
Countries
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Central Contacts
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References
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Nejman D, Livyatan I, Fuks G, Gavert N, Zwang Y, Geller LT, Rotter-Maskowitz A, Weiser R, Mallel G, Gigi E, Meltser A, Douglas GM, Kamer I, Gopalakrishnan V, Dadosh T, Levin-Zaidman S, Avnet S, Atlan T, Cooper ZA, Arora R, Cogdill AP, Khan MAW, Ologun G, Bussi Y, Weinberger A, Lotan-Pompan M, Golani O, Perry G, Rokah M, Bahar-Shany K, Rozeman EA, Blank CU, Ronai A, Shaoul R, Amit A, Dorfman T, Kremer R, Cohen ZR, Harnof S, Siegal T, Yehuda-Shnaidman E, Gal-Yam EN, Shapira H, Baldini N, Langille MGI, Ben-Nun A, Kaufman B, Nissan A, Golan T, Dadiani M, Levanon K, Bar J, Yust-Katz S, Barshack I, Peeper DS, Raz DJ, Segal E, Wargo JA, Sandbank J, Shental N, Straussman R. The human tumor microbiome is composed of tumor type-specific intracellular bacteria. Science. 2020 May 29;368(6494):973-980. doi: 10.1126/science.aay9189.
Banerjee S, Tian T, Wei Z, Shih N, Feldman MD, Alwine JC, Coukos G, Robertson ES. The ovarian cancer oncobiome. Oncotarget. 2017 May 30;8(22):36225-36245. doi: 10.18632/oncotarget.16717.
Yang J, Huang S, Cheng S, Jin Y, Zhang N, Wang Y. Application of Ovarian Cancer Organoids in Precision Medicine: Key Challenges and Current Opportunities. Front Cell Dev Biol. 2021 Aug 2;9:701429. doi: 10.3389/fcell.2021.701429. eCollection 2021.
Ranhotra HS, Flannigan KL, Brave M, Mukherjee S, Lukin DJ, Hirota SA, Mani S. Xenobiotic Receptor-Mediated Regulation of Intestinal Barrier Function and Innate Immunity. Nucl Receptor Res. 2016;3:101199. doi: 10.11131/2016/101199.
Hezaveh K, Shinde RS, Klotgen A, Halaby MJ, Lamorte S, Ciudad MT, Quevedo R, Neufeld L, Liu ZQ, Jin R, Grunwald BT, Foerster EG, Chaharlangi D, Guo M, Makhijani P, Zhang X, Pugh TJ, Pinto DM, Co IL, McGuigan AP, Jang GH, Khokha R, Ohashi PS, O'Kane GM, Gallinger S, Navarre WW, Maughan H, Philpott DJ, Brooks DG, McGaha TL. Tryptophan-derived microbial metabolites activate the aryl hydrocarbon receptor in tumor-associated macrophages to suppress anti-tumor immunity. Immunity. 2022 Feb 8;55(2):324-340.e8. doi: 10.1016/j.immuni.2022.01.006.
Tuveson D, Clevers H. Cancer modeling meets human organoid technology. Science. 2019 Jun 7;364(6444):952-955. doi: 10.1126/science.aaw6985.
Ricci F, Bizzaro F, Cesca M, Guffanti F, Ganzinelli M, Decio A, Ghilardi C, Perego P, Fruscio R, Buda A, Milani R, Ostano P, Chiorino G, Bani MR, Damia G, Giavazzi R. Patient-derived ovarian tumor xenografts recapitulate human clinicopathology and genetic alterations. Cancer Res. 2014 Dec 1;74(23):6980-90. doi: 10.1158/0008-5472.CAN-14-0274. Epub 2014 Oct 10.
Arcieri M, Capezzali E, Restaino S, Pregnolato S, Mariuzzi L, Mangogna A, Orsaria M, Tulisso A, Tonon S, De Martino M, Isola M, Driul L, Pucillo C, Scambia G, Frossi B, Vizzielli G. Study of the Role of the Tumor Microenvironment in Ovarian Cancer (MICO): A Prospective Monocentric Trial. Cancer Rep (Hoboken). 2025 Jun;8(6):e70242. doi: 10.1002/cnr2.70242.
Other Identifiers
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17380
Identifier Type: -
Identifier Source: org_study_id
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