Tumor Microenvironment in Ovarian Cancer

NCT06272240 | Recruiting

• 1 other identifier: 17380
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Ovarian Cancer Stage III; Ovarian Cancer Stage IV

Keywords

organoids,tumor microenviroment,ovarian cancer

Outcome Measures

Primary Outcomes (1)

• • Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids

  Characterize the composition of the tumor microenvironment (including the immune system and intratumoral microbiota). Generate organoids from cells derived from ovarian tissue.

  from enrollment to the end of follow up at 36 months

Interventions

Ovarian Cancer Organoids OTHER

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

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary diagnosis (t=0) of epithelial ovarian cancer (stage III and IV according to FIGO)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Udine: lead

Study Sites (1)

Università degli Studi di Udine

Udine, UD, 33100, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 32467386 BACKGROUND

• 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.

  PMID: 28410234 BACKGROUND

• 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.

  PMID: 34409036 BACKGROUND

• 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.

  PMID: 27942535 BACKGROUND

• 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.

  PMID: 35139353 BACKGROUND

• Tuveson D, Clevers H. Cancer modeling meets human organoid technology. Science. 2019 Jun 7;364(6444):952-955. doi: 10.1126/science.aaw6985.

  PMID: 31171691 BACKGROUND

• 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.

  PMID: 25304260 BACKGROUND

• 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.

  PMID: 40464605 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients with primary diagnosis (t=0) of epithelial ovarian cancer (stage III and IV according to FIGO) cadidate for surgical removal will be selected. The removed tissue will be sent to the Pathology Department, where it will be selected by the pathologist, who will collect a fragment of tumor tissue and one from adjacent normal tissue (as a healthy control) and will divide them into three parts: 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.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Giuseppe Vizzielli, Prof.

CONTACT

3403990822; giuseppe.vizzielli@uniud.it

Arcieri Martina, Dott.ssa

CONTACT

3478114704; martina.arcieri@asufc.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: January 2, 2024
• Primary Completion: July 1, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 22, 2024

Record last verified: 2024-01

Locations

IT (1)