High Grade Serous Ovarian CancerMR-O-MICSNCT06084195
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
A study testing Blood sample and tissue sample in people with High Grade Serous Ovarian Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Serous Ovarian Cancer
- What is being tested?
- Blood sample and tissue sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2023to Oct 2030
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged >18
- Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment
- Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,
- Patient who has given informed, written and express consent,
- Patient affiliated with a French health insurance scheme.
Who cannot join
- Early-stage disease (FIGO <IIIB) or presence of extraperitoneal metastases,
- Patient who will not have surgery
- Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
- Patient under guardianship, curatorship or safeguarding of justice,
- Pregnant and/or nursing patient,
- Patient with a history of other cancers within 5 years/10 years prior to inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
NOUGARET Stephanie
Montpellier, 34298
NOUGARET Stephanie, MD, stephanie.nougaret@icm.unicancer.fr
About this study
The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance
Read the detailed description
After being informed about the study and potential risks, all patient giving wirtting informed consent.
During surgery, tissue and blood samples will be conserved for the study. In this study will be compared images obtained in vivo before surgical management, ex vivo images obtained on excised tissues during surgery, histological data obtained during surgery.
- Conditions
- High Grade Serous Ovarian Cancer
- Being tested
- Blood sample and tissue sample
- Keywords
- Radiomics, Ovarian cancer, Genomics, Proteomics, Immune Tumor Microenvironment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample and tissue sampleBiological
During the surgery :
- Tissus sample : primary tumor and metastasis
- blood sample : 3 EDTA tubes
- ex vivo MRI data
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | single arm Receives: Biological: Blood sample and tissue sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cancer.
The diagnostic performance of the radiomic and multiomic algorithm for the characterization of heterogeneity in the CSOHG.
Measured: one shoot at the surgery
Secondary outcomes (4)
the imaging phenotype of tumor heterogeneity with a multi-scale radiomic approach by obtaining the image mirror tumor at the in vivo scale
Correlation between radiomic maps and pathogenic maps of heterogeneity,
Measured: one shoot at the surgery
tumor heterogeneity based on phenotypic imaging supported by AI reflects and can predict sub-histologyunderlying by tumor stroma proportion and tumor density infiltrating lymphocytes and genomics through HRD
Correlation between radiomic algorithms and i/underlying histology and ii/ genomics
Measured: one shoot at the surgery
the heterogeneity of the tumor biology of CSOHG through non-invasive habitat imaging combined with an integrated Multi-O-Mics approach.
Correlation between radiomic maps and tumor biology (CYTOF, proteomics and transcriptomics),
Measured: one shoot at the surgery
To Correlate MRI results with hematological molecular biology results.
Correlation between radiomic algorithms for tumor detection and cDNA determination.
Measured: one shoot at the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start19 Dec 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for High Grade Serous Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NOUGARET Stephanie, MD, Study director, INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084195
- Sponsor's protocol ID
- PROICM 2023-02 MRO
- Acronym
- MR-O-MICS
- Status last verified
- Nov 2026
- First submitted
- 2 Oct 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torre LA, Trabert B, DeSantis CE, Miller KD, Samimi G, Runowicz CD, Gaudet MM, Jemal A, Siegel RL. Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018 Jul;68(4):284-296. doi: 10.3322/caac.21456. Epub 2018 May 29.
PubMed 29809280Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
PubMed 16394300Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.
PubMed 20818904van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.
PubMed 29342393Jayson GC, Kohn EC, Kitchener HC, Ledermann JA. Ovarian cancer. Lancet. 2014 Oct 11;384(9951):1376-88. doi: 10.1016/S0140-6736(13)62146-7. Epub 2014 Apr 21.
PubMed 24767708Cancer Genome Atlas Research Network. Integrated genomic analyses of ovarian carcinoma. Nature. 2011 Jun 29;474(7353):609-15. doi: 10.1038/nature10166.
PubMed 21720365Cooke SL, Brenton JD. Evolution of platinum resistance in high-grade serous ovarian cancer. Lancet Oncol. 2011 Nov;12(12):1169-74. doi: 10.1016/S1470-2045(11)70123-1.
PubMed 21742554McPherson A, Roth A, Laks E, Masud T, Bashashati A, Zhang AW, Ha G, Biele J, Yap D, Wan A, Prentice LM, Khattra J, Smith MA, Nielsen CB, Mullaly SC, Kalloger S, Karnezis A, Shumansky K, Siu C, Rosner J, Chan HL, Ho J, Melnyk N, Senz J, Yang W, Moore R, Mungall AJ, Marra MA, Bouchard-Cote A, Gilks CB, Huntsman DG, McAlpine JN, Aparicio S, Shah SP. Divergent modes of clonal spread and intraperitoneal mixing in high-grade serous ovarian cancer. Nat Genet. 2016 Jul;48(7):758-67. doi: 10.1038/ng.3573. Epub 2016 May 16.
PubMed 27182968Burrell RA, Swanton C. Tumour heterogeneity and the evolution of polyclonal drug resistance. Mol Oncol. 2014 Sep 12;8(6):1095-111. doi: 10.1016/j.molonc.2014.06.005. Epub 2014 Jul 10.
PubMed 25087573Hoogstraat M, de Pagter MS, Cirkel GA, van Roosmalen MJ, Harkins TT, Duran K, Kreeftmeijer J, Renkens I, Witteveen PO, Lee CC, Nijman IJ, Guy T, van 't Slot R, Jonges TN, Lolkema MP, Koudijs MJ, Zweemer RP, Voest EE, Cuppen E, Kloosterman WP. Genomic and transcriptomic plasticity in treatment-naive ovarian cancer. Genome Res. 2014 Feb;24(2):200-11. doi: 10.1101/gr.161026.113. Epub 2013 Nov 12.
PubMed 24221193Lee JY, Yoon JK, Kim B, Kim S, Kim MA, Lim H, Bang D, Song YS. Tumor evolution and intratumor heterogeneity of an epithelial ovarian cancer investigated using next-generation sequencing. BMC Cancer. 2015 Feb 26;15:85. doi: 10.1186/s12885-015-1077-4.
PubMed 25881093Schwarz RF, Ng CK, Cooke SL, Newman S, Temple J, Piskorz AM, Gale D, Sayal K, Murtaza M, Baldwin PJ, Rosenfeld N, Earl HM, Sala E, Jimenez-Linan M, Parkinson CA, Markowetz F, Brenton JD. Spatial and temporal heterogeneity in high-grade serous ovarian cancer: a phylogenetic analysis. PLoS Med. 2015 Feb 24;12(2):e1001789. doi: 10.1371/journal.pmed.1001789. eCollection 2015 Feb.
PubMed 25710373Bashashati A, Ha G, Tone A, Ding J, Prentice LM, Roth A, Rosner J, Shumansky K, Kalloger S, Senz J, Yang W, McConechy M, Melnyk N, Anglesio M, Luk MT, Tse K, Zeng T, Moore R, Zhao Y, Marra MA, Gilks B, Yip S, Huntsman DG, McAlpine JN, Shah SP. Distinct evolutionary trajectories of primary high-grade serous ovarian cancers revealed through spatial mutational profiling. J Pathol. 2013 Sep;231(1):21-34. doi: 10.1002/path.4230.
PubMed 23780408Greaves M, Maley CC. Clonal evolution in cancer. Nature. 2012 Jan 18;481(7381):306-13. doi: 10.1038/nature10762.
PubMed 22258609Zhang AW, McPherson A, Milne K, Kroeger DR, Hamilton PT, Miranda A, Funnell T, Little N, de Souza CPE, Laan S, LeDoux S, Cochrane DR, Lim JLP, Yang W, Roth A, Smith MA, Ho J, Tse K, Zeng T, Shlafman I, Mayo MR, Moore R, Failmezger H, Heindl A, Wang YK, Bashashati A, Grewal DS, Brown SD, Lai D, Wan ANC, Nielsen CB, Huebner C, Tessier-Cloutier B, Anglesio MS, Bouchard-Cote A, Yuan Y, Wasserman WW, Gilks CB, Karnezis AN, Aparicio S, McAlpine JN, Huntsman DG, Holt RA, Nelson BH, Shah SP. Interfaces of Malignant and Immunologic Clonal Dynamics in Ovarian Cancer. Cell. 2018 Jun 14;173(7):1755-1769.e22. doi: 10.1016/j.cell.2018.03.073. Epub 2018 May 10.
PubMed 29754820
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
- ClinicalTrials.gov ID
- NCT06084195
- Acronym / sponsor ID
- MR-O-MICS / PROICM 2023-02 MRO
- Conditions
- High Grade Serous Ovarian Cancer
- Keywords
- Radiomics, Ovarian cancer, Genomics, Proteomics, Immune Tumor Microenvironment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 16 Oct 2023 (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.
The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance
Detailed description
After being informed about the study and potential risks, all patient giving wirtting informed consent.
During surgery, tissue and blood samples will be conserved for the study. In this study will be compared images obtained in vivo before surgical management, ex vivo images obtained on excised tissues during surgery, histological data obtained during surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: Blood sample and tissue samplesingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged >18
- Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment
- Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,
- Patient who has given informed, written and express consent,
- Patient affiliated with a French health insurance scheme.
Key exclusion criteria (6 listed)
- Early-stage disease (FIGO <IIIB) or presence of extraperitoneal metastases,
- Patient who will not have surgery
- Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
- Patient under guardianship, curatorship or safeguarding of justice,
- Pregnant and/or nursing patient,
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 |
|---|---|---|
| Blood sample and tissue sampleDuring the surgery : * Tissus sample : primary tumor and metastasis * blood sample : 3 EDTA tubes * ex vivo MRI data | Biological | Single arm |
Primary outcome
the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cancer.
Time frame: one shoot at the surgery
The diagnostic performance of the radiomic and multiomic algorithm for the characterization of heterogeneity in the CSOHG.
4 secondary outcomes
the imaging phenotype of tumor heterogeneity with a multi-scale radiomic approach by obtaining the image mirror tumor at the in vivo scale
Time frame: one shoot at the surgery
tumor heterogeneity based on phenotypic imaging supported by AI reflects and can predict sub-histologyunderlying by tumor stroma proportion and tumor density infiltrating lymphocytes and genomics through HRD
Time frame: one shoot at the surgery
the heterogeneity of the tumor biology of CSOHG through non-invasive habitat imaging combined with an integrated Multi-O-Mics approach.
Time frame: one shoot at the surgery
To Correlate MRI results with hematological molecular biology results.
Time frame: one shoot at the surgery
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 6 Nov 2026.
- Background: PubMed 29809280Torre LA, Trabert B, DeSantis CE, Miller KD, Samimi G, Runowicz CD, Gaudet MM, Jemal A, Siegel RL. Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018 Jul;68(4):284-296. doi: 10.3322/caac.21456. Epub 2018 May 29.
- Background: PubMed 16394300Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
- Background: PubMed 20818904Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.
- Background: PubMed 29342393van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.
- Background: PubMed 24767708Jayson GC, Kohn EC, Kitchener HC, Ledermann JA. Ovarian cancer. Lancet. 2014 Oct 11;384(9951):1376-88. doi: 10.1016/S0140-6736(13)62146-7. Epub 2014 Apr 21.
- Background: PubMed 21720365Cancer Genome Atlas Research Network. Integrated genomic analyses of ovarian carcinoma. Nature. 2011 Jun 29;474(7353):609-15. doi: 10.1038/nature10166.
- Background: PubMed 21742554Cooke SL, Brenton JD. Evolution of platinum resistance in high-grade serous ovarian cancer. Lancet Oncol. 2011 Nov;12(12):1169-74. doi: 10.1016/S1470-2045(11)70123-1.
- Background: PubMed 27182968McPherson A, Roth A, Laks E, Masud T, Bashashati A, Zhang AW, Ha G, Biele J, Yap D, Wan A, Prentice LM, Khattra J, Smith MA, Nielsen CB, Mullaly SC, Kalloger S, Karnezis A, Shumansky K, Siu C, Rosner J, Chan HL, Ho J, Melnyk N, Senz J, Yang W, Moore R, Mungall AJ, Marra MA, Bouchard-Cote A, Gilks CB, Huntsman DG, McAlpine JN, Aparicio S, Shah SP. Divergent modes of clonal spread and intraperitoneal mixing in high-grade serous ovarian cancer. Nat Genet. 2016 Jul;48(7):758-67. doi: 10.1038/ng.3573. Epub 2016 May 16.
- Background: PubMed 25087573Burrell RA, Swanton C. Tumour heterogeneity and the evolution of polyclonal drug resistance. Mol Oncol. 2014 Sep 12;8(6):1095-111. doi: 10.1016/j.molonc.2014.06.005. Epub 2014 Jul 10.
- Background: PubMed 24221193Hoogstraat M, de Pagter MS, Cirkel GA, van Roosmalen MJ, Harkins TT, Duran K, Kreeftmeijer J, Renkens I, Witteveen PO, Lee CC, Nijman IJ, Guy T, van 't Slot R, Jonges TN, Lolkema MP, Koudijs MJ, Zweemer RP, Voest EE, Cuppen E, Kloosterman WP. Genomic and transcriptomic plasticity in treatment-naive ovarian cancer. Genome Res. 2014 Feb;24(2):200-11. doi: 10.1101/gr.161026.113. Epub 2013 Nov 12.
- Background: PubMed 25881093Lee JY, Yoon JK, Kim B, Kim S, Kim MA, Lim H, Bang D, Song YS. Tumor evolution and intratumor heterogeneity of an epithelial ovarian cancer investigated using next-generation sequencing. BMC Cancer. 2015 Feb 26;15:85. doi: 10.1186/s12885-015-1077-4.
- Background: PubMed 25710373Schwarz RF, Ng CK, Cooke SL, Newman S, Temple J, Piskorz AM, Gale D, Sayal K, Murtaza M, Baldwin PJ, Rosenfeld N, Earl HM, Sala E, Jimenez-Linan M, Parkinson CA, Markowetz F, Brenton JD. Spatial and temporal heterogeneity in high-grade serous ovarian cancer: a phylogenetic analysis. PLoS Med. 2015 Feb 24;12(2):e1001789. doi: 10.1371/journal.pmed.1001789. eCollection 2015 Feb.
- Individual participant dataSharing planned: No
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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.
NOUGARET Stephanie, MD study director
INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and tissue sample in people with High Grade Serous Ovarian Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 5 inclusion and 6 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 6 Nov 2026. 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 France. 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 MOUSSION Aurore (0467613102 ext. +33, aurore.moussion@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cancer. (time frame: one shoot at the surgery). 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 NCT06084195, which also lists 35 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 6 Nov 2026.