Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:18 AM
Study NCT ID:
NCT07360834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'C536928', 'term': 'Turcot syndrome'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether a multimodal surveillance strategy - using combining concurrent circulating tumor DNA (ctDNA), urine tumor DNA (utDNA), vaginal swab tumor DNA (vsDNA), and stool (qFIT) - is non-inferior to standard-of-care screening surveillance', 'timeFrame': 'Baseline, month 12, month 24, month 36, month 48', 'description': 'Number of newly diagnosed histologically confirmed invasive cancers (CRC, EC, UC) during surveillance and follow-up phases, expressed as cumulative incidence (%) and incidence per 1,000 person-years.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lynch Syndrome, hereditary cancer, MMR deficiency, Liquid biopsies, cancer early detection.', 'Lynch Syndrome, MMR deficiency, Liquid biopsies'], 'conditions': ['Lynch Syndrome']}, 'referencesModule': {'references': [{'pmid': '38789506', 'type': 'BACKGROUND', 'citation': 'Gallon R, Brekelmans C, Martin M, Bours V, Schamschula E, Amberger A, Muleris M, Colas C, Dekervel J, De Hertogh G, Coupier J, Colleye O, Sepulchre E, Burn J, Brems H, Legius E, Wimmer K. Constitutional mismatch repair deficiency mimicking Lynch syndrome is associated with hypomorphic mismatch repair gene variants. NPJ Precis Oncol. 2024 May 24;8(1):119. doi: 10.1038/s41698-024-00603-z.'}, {'pmid': '38504268', 'type': 'BACKGROUND', 'citation': 'Wu J, Lin Y, Yang K, Liu X, Wang H, Yu T, Tao R, Guo J, Chen L, Cheng H, Lou F, Cao S, Yu W, Hu H, Ye D. Clinical effectiveness of a multitarget urine DNA test for urothelial carcinoma detection: a double-blinded, multicenter, prospective trial. Mol Cancer. 2024 Mar 19;23(1):57. doi: 10.1186/s12943-024-01974-4.'}, {'pmid': '31383735', 'type': 'BACKGROUND', 'citation': 'Willis J, Lefterova MI, Artyomenko A, Kasi PM, Nakamura Y, Mody K, Catenacci DVT, Fakih M, Barbacioru C, Zhao J, Sikora M, Fairclough SR, Lee H, Kim KM, Kim ST, Kim J, Gavino D, Benavides M, Peled N, Nguyen T, Cusnir M, Eskander RN, Azzi G, Yoshino T, Banks KC, Raymond VM, Lanman RB, Chudova DI, Talasaz A, Kopetz S, Lee J, Odegaard JI. Validation of Microsatellite Instability Detection Using a Comprehensive Plasma-Based Genotyping Panel. Clin Cancer Res. 2019 Dec 1;25(23):7035-7045. doi: 10.1158/1078-0432.CCR-19-1324. Epub 2019 Aug 4.'}, {'pmid': '37171677', 'type': 'BACKGROUND', 'citation': 'van Liere ELSA, Jacobs IL, Dekker E, Jacobs MAJM, de Boer NKH, Ramsoekh D. Colonoscopy surveillance in Lynch syndrome is burdensome and frequently delayed. Fam Cancer. 2023 Oct;22(4):403-411. doi: 10.1007/s10689-023-00333-4. Epub 2023 May 12.'}, {'pmid': '26657901', 'type': 'BACKGROUND', 'citation': 'Moller P, Seppala T, Bernstein I, Holinski-Feder E, Sala P, Evans DG, Lindblom A, Macrae F, Blanco I, Sijmons R, Jeffries J, Vasen H, Burn J, Nakken S, Hovig E, Rodland EA, Tharmaratnam K, de Vos Tot Nederveen Cappel WH, Hill J, Wijnen J, Green K, Lalloo F, Sunde L, Mints M, Bertario L, Pineda M, Navarro M, Morak M, Renkonen-Sinisalo L, Frayling IM, Plazzer JP, Pylvanainen K, Sampson JR, Capella G, Mecklin JP, Moslein G; Mallorca Group (http://mallorca-group.eu). Cancer incidence and survival in Lynch syndrome patients receiving colonoscopic and gynaecological surveillance: first report from the prospective Lynch syndrome database. Gut. 2017 Mar;66(3):464-472. doi: 10.1136/gutjnl-2015-309675. Epub 2015 Dec 9.'}, {'pmid': '31394082', 'type': 'BACKGROUND', 'citation': 'Stoffel EM, Murphy CC. Epidemiology and Mechanisms of the Increasing Incidence of Colon and Rectal Cancers in Young Adults. Gastroenterology. 2020 Jan;158(2):341-353. doi: 10.1053/j.gastro.2019.07.055. Epub 2019 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'Lynch syndrome is an inherited genetic predisposition that increases the risk of developing several types of cancer, particularly colon and rectal cancers (colorectal cancer), as well as cancer of the uterine lining (endometrial cancer). It affects around 1 in 400 people in Europe.\n\nToday, surveillance mainly relies on examinations such as colonoscopy (an examination of the colon using a camera) or gynaecological evaluations, sometimes accompanied by biopsies (the removal of a small tissue sample for microscopic analysis). Although effective, these procedures are invasive and demanding; they can affect quality of life and discourage some individuals from adhering to their recommended surveillance programme.\n\nThe European project PREDI-LYNCH is exploring an additional pathway that is simpler and better tolerated. This project relies on "liquid biopsies", meaning tests performed on easily collected samples such as blood, urine, stool, and vaginal swabs for women with a uterus. The PREDI-LYNCH study aims to determine whether these non-invasive tests could enable personalised surveillance and potentially increase the interval between more burdensome procedures, while maintaining a high level of medical safety.', 'detailedDescription': 'This European clinical study evaluates whether non-invasive liquid biopsy tests (blood, urine, stool and vaginal samples when applicable) can improve cancer surveillance in adults with genetically confirmed Lynch syndrome (MLH1, MSH2, MSH6 or EPCAM). The trial compares two strategies: standard follow-up with colonoscopy every 18 months versus an approach combining annual liquid biopsies with a colonoscopy every 36 months. The main outcome is the number of new cancer cases diagnosed, confirmed by standard procedures. Secondary outcomes include early cancer detection, lesion identification, diagnostic timing, feasibility, quality of life and healthcare use. Each positive test leads to fast confirmatory exams. The aim is to determine if liquid biopsies can safely reduce invasive procedures while maintaining effective cancer monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Age 35-80\n3. Genetically confirmed class 4-5 (likely pathogenic (LP) or pathogenic (P) variant, respectively) in MLH1, MSH2, MSH6, or EPCAM gene.\n4. The participant should be insurance covered for the financial costs of the standard surveillance and healthcare related to LS, such as affiliated to Social Security System\n\nExclusion Criteria:\n\n1. Previously performed proctocolectomy or equivalent (entire colon and rectum removed)\n2. Active treatment for cancer within 2 years prior to inclusion.\n3. Checkpoint inhibitor therapy within 12 months\n4. Pregnancy\n5. Participants unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n6. Persons deprived of their liberty or under protective custody or guardianship."}, 'identificationModule': {'nctId': 'NCT07360834', 'acronym': 'PREDI-LYNCH', 'briefTitle': 'Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'UNICANCER'}, 'officialTitle': 'Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies', 'orgStudyIdInfo': {'id': 'UC-GIG-2522'}, 'secondaryIdInfos': [{'id': 'Project 101213916', 'type': 'OTHER_GRANT', 'domain': 'EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Biopsies Liquids +/- Colonoscopy', 'interventionNames': ['Diagnostic Test: INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY']}, {'type': 'OTHER', 'label': 'Control arm', 'description': 'Colonoscopy each 18 months', 'interventionNames': ['Diagnostic Test: INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY']}], 'interventions': [{'name': 'INVITRO DIAGNOSTIC TESTS AND COLONOSCOPY', 'type': 'DIAGNOSTIC_TEST', 'description': 'The trial compares two strategies: standard follow-up with colonoscopy every 18 months versus an approach combining annual liquid biopsies with a colonoscopy every 36 months', 'armGroupLabels': ['Control arm', 'Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagreb', 'country': 'Croatia', 'contacts': [{'name': 'Iva Kirac', 'role': 'CONTACT', 'email': 'iva.kirac@kbcsm.hr'}], 'facility': 'Klinicki Bolnicki Centar Sestre Milosrdnice Ustanova', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Brno', 'country': 'Czechia', 'contacts': [{'name': 'Marek Svoboda', 'role': 'CONTACT', 'email': 'msvoboda@mou.cz', 'phone': '+420 543 134 103'}], 'facility': 'Masaryk Memorial Cancer Institute', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Helsinki', 'country': 'Finland', 'contacts': [{'name': 'Toni Seppala', 'role': 'CONTACT', 'email': 'toni.seppala@tuni.fi', 'phone': '+358444722846'}], 'facility': 'Tampereen Korkeakoulusäätiö SR', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Amina Ghorbel', 'role': 'CONTACT', 'email': 'a-ghorbel@unicancer.fr', 'phone': '0668502012'}, {'name': 'Chrystelle Colas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GGC Network', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Marco Vittellaro', 'role': 'CONTACT', 'email': 'marco.vitellaro@istitutotumori.mi.it', 'phone': '+39 02.2390 2540'}], 'facility': 'Ist. Tumori di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Riga', 'country': 'Latvia', 'contacts': [{'name': 'Arvids Irmeis', 'role': 'CONTACT', 'email': 'arvids.irmejs@rsu.lv', 'phone': '+371 29171604'}], 'facility': 'Pauls Stradins Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'contacts': [{'name': 'Anja Wagner', 'role': 'CONTACT', 'email': 'a.wagner@erasmusmc.nl', 'phone': '0031107036913'}], 'facility': 'Erasmus Medisch Centrum Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Oslo', 'country': 'Norway', 'contacts': [{'name': 'Marte Lie Høivik', 'role': 'CONTACT', 'email': 'm.l.hoivik@medisin.uio.no', 'phone': '+47 924 37 392'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'contacts': [{'name': 'Neil Ryan', 'role': 'CONTACT', 'email': 'neil.ryan@ed.ac.uk', 'phone': '+1 778 223 9770'}], 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'centralContacts': [{'name': 'Amina Ghorbel, PhD', 'role': 'CONTACT', 'email': 'a-ghorbel@unicancer.fr', 'phone': '+33 (0) 6 68 50 20 12'}], 'overallOfficials': [{'name': 'Chrystelle Colas, Oncogeneticist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Curie'}, {'name': 'Toni Seppala, Surgeon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TAMPERE University (Finland)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNICANCER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}