Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-31 @ 9:23 AM
Study NCT ID:
NCT06084195
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2023-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
Sponsor:
Organization:
Raw JSON
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Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018 Jul;68(4):284-296. doi: 10.3322/caac.21456. Epub 2018 May 29.'}, {'pmid': '16394300', 'type': 'BACKGROUND', 'citation': 'Armstrong 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.'}, {'pmid': '20818904', 'type': 'BACKGROUND', 'citation': 'Vergote 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. 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Nature. 2011 Jun 29;474(7353):609-15. doi: 10.1038/nature10166.'}, {'pmid': '21742554', 'type': 'BACKGROUND', 'citation': 'Cooke 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.'}, {'pmid': '27182968', 'type': 'BACKGROUND', 'citation': 'McPherson 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.'}, {'pmid': '25087573', 'type': 'BACKGROUND', 'citation': 'Burrell RA, Swanton C. 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Epub 2018 May 10.'}, {'pmid': '28841418', 'type': 'BACKGROUND', 'citation': 'Jimenez-Sanchez A, Memon D, Pourpe S, Veeraraghavan H, Li Y, Vargas HA, Gill MB, Park KJ, Zivanovic O, Konner J, Ricca J, Zamarin D, Walther T, Aghajanian C, Wolchok JD, Sala E, Merghoub T, Snyder A, Miller ML. Heterogeneous Tumor-Immune Microenvironments among Differentially Growing Metastases in an Ovarian Cancer Patient. Cell. 2017 Aug 24;170(5):927-938.e20. doi: 10.1016/j.cell.2017.07.025.'}, {'pmid': '32483290', 'type': 'BACKGROUND', 'citation': 'Jimenez-Sanchez A, Cybulska P, Mager KL, Koplev S, Cast O, Couturier DL, Memon D, Selenica P, Nikolovski I, Mazaheri Y, Bykov Y, Geyer FC, Macintyre G, Gavarro LM, Drews RM, Gill MB, Papanastasiou AD, Sosa RE, Soslow RA, Walther T, Shen R, Chi DS, Park KJ, Hollmann T, Reis-Filho JS, Markowetz F, Beltrao P, Vargas HA, Zamarin D, Brenton JD, Snyder A, Weigelt B, Sala E, Miller ML. 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Epub 2013 Dec 11.'}, {'pmid': '32154773', 'type': 'BACKGROUND', 'citation': 'Zwanenburg A, Vallieres M, Abdalah MA, Aerts HJWL, Andrearczyk V, Apte A, Ashrafinia S, Bakas S, Beukinga RJ, Boellaard R, Bogowicz M, Boldrini L, Buvat I, Cook GJR, Davatzikos C, Depeursinge A, Desseroit MC, Dinapoli N, Dinh CV, Echegaray S, El Naqa I, Fedorov AY, Gatta R, Gillies RJ, Goh V, Gotz M, Guckenberger M, Ha SM, Hatt M, Isensee F, Lambin P, Leger S, Leijenaar RTH, Lenkowicz J, Lippert F, Losnegard A, Maier-Hein KH, Morin O, Muller H, Napel S, Nioche C, Orlhac F, Pati S, Pfaehler EAG, Rahmim A, Rao AUK, Scherer J, Siddique MM, Sijtsema NM, Socarras Fernandez J, Spezi E, Steenbakkers RJHM, Tanadini-Lang S, Thorwarth D, Troost EGC, Upadhaya T, Valentini V, van Dijk LV, van Griethuysen J, van Velden FHP, Whybra P, Richter C, Lock S. The Image Biomarker Standardization Initiative: Standardized Quantitative Radiomics for High-Throughput Image-based Phenotyping. 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No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'After being informed about the study and potential risks, all patient giving wirtting informed consent.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged \\>18\n* Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment\n* Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,\n* Patient who has given informed, written and express consent,\n* Patient affiliated with a French health insurance scheme.\n\nExclusion Criteria:\n\n* Early-stage disease (FIGO \\<IIIB) or presence of extraperitoneal metastases,\n* Patient who will not have surgery\n* Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,\n* Patient under guardianship, curatorship or safeguarding of justice,\n* Pregnant and/or nursing patient,\n* Patient with a history of other cancers within 5 years/10 years prior to inclusion'}, 'identificationModule': {'nctId': 'NCT06084195', 'acronym': 'MR-O-MICS', 'briefTitle': 'Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging', 'orgStudyIdInfo': {'id': 'PROICM 2023-02 MRO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'single arm', 'interventionNames': ['Biological: Blood sample and tissue sample']}], 'interventions': [{'name': 'Blood sample and tissue sample', 'type': 'BIOLOGICAL', 'description': 'During the surgery :\n\n* Tissus sample : primary tumor and metastasis\n* blood sample : 3 EDTA tubes\n* ex vivo MRI data', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'NOUGARET Stephanie, MD', 'role': 'CONTACT', 'email': 'stephanie.nougaret@icm.unicancer.fr'}], 'facility': 'NOUGARET Stephanie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'MOUSSION Aurore', 'role': 'CONTACT', 'email': 'aurore.moussion@icm.unicancer.fr', 'phone': '0467613102', 'phoneExt': '+33'}, {'name': 'Texier Emmanuelle', 'role': 'CONTACT', 'email': 'emmanuelle.texier@icm.unicancer.fr', 'phone': '0467613102', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'NOUGARET Stephanie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}