Ovarian Cancer Stage IIIMICONCT06272240
Tumor Microenvironment in Ovarian Cancer
An observational study of Ovarian Cancer Stage III and Ovarian Cancer Stage IV, run by University of Udine at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- What is being tested?
- Ovarian Cancer Organoids
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2024to Jan 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary diagnosis (t=0) of epithelial ovarian cancer (stage III and IV according to FIGO)
Who may be able to join
- Age > 18 years
- Age < 80 years
- Serous ovarian carcinoma
- FIGO Stage III-IV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università degli Studi di Udine
Udine, UD, 33100
About this study
Official title: Study of the Role of the Tumor Microenvironment in Ovarian Cancer
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).
Read the 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.
- Conditions
- Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- Being tested
- Ovarian Cancer Organoids
- Keywords
- organoids,tumor microenviroment,ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian Cancer OrganoidsOther
To characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules)
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: from enrollment to the end of follow up at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start2 Jan 2024
- Primary completionJul 2024 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ovarian Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272240
- Sponsor's protocol ID
- 17380
- Acronym
- MICO
- Status last verified
- Jan 2024
- First submitted
- 14 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32467386Banerjee 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.
PubMed 28410234Yang 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.
PubMed 34409036Ranhotra 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.
PubMed 27942535Hezaveh 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.
PubMed 35139353Tuveson D, Clevers H. Cancer modeling meets human organoid technology. Science. 2019 Jun 7;364(6444):952-955. doi: 10.1126/science.aaw6985.
PubMed 31171691Ricci 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.
PubMed 25304260Arcieri 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.
PubMed 40464605
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of the Tumor Microenvironment in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06272240
- Acronym / sponsor ID
- MICO / 17380
- Conditions
- Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- Keywords
- organoids,tumor microenviroment,ovarian cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary diagnosis (t=0) of epithelial ovarian cancer (stage III and IV according to FIGO)
Key inclusion criteria (4 listed)
- Age > 18 years
- Age < 80 years
- Serous ovarian carcinoma
- FIGO Stage III-IV
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian Cancer OrganoidsTo characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules) | Other | – |
Primary outcome
• Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids
Time frame: from enrollment to the end of follow up at 36 months
Characterize the composition of the tumor microenvironment (including the immune system and intratumoral microbiota). Generate organoids from cells derived from ovarian tissue.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 32467386Nejman 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.
- Background: PubMed 28410234Banerjee 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.
- Background: PubMed 34409036Yang 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.
- Background: PubMed 27942535Ranhotra 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.
- Background: PubMed 35139353Hezaveh 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.
- Background: PubMed 31171691Tuveson D, Clevers H. Cancer modeling meets human organoid technology. Science. 2019 Jun 7;364(6444):952-955. doi: 10.1126/science.aaw6985.
- Background: PubMed 25304260Ricci 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.
- Derived from this study: PubMed 40464605Arcieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer Stage III and Ovarian Cancer Stage IV, run by University of Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Vizzielli, Prof. (3403990822, giuseppe.vizzielli@uniud.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids (time frame: from enrollment to the end of follow up at 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06272240, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.