Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT06111105
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing CtDNA Diagnostics - Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Full blood samples processed into plasma, buffy coat, and serum Formalin-fixed paraffin-embedded tumor tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of clinical plasma samples at relevant time points', 'timeFrame': '8 months after end of recruitment', 'description': 'For head-to-head performance assessment and benchmarking of ctDNA diagnostics'}], 'secondaryOutcomes': [{'measure': 'The 3-year recurrence-free survival', 'timeFrame': '3 years after end of recruitment'}, {'measure': 'Lead time between ctDNA detection and clinical recurrence', 'timeFrame': '3 years after end of recruitment'}, {'measure': 'Prognostic value of ctDNA analysis at relevant time points', 'timeFrame': '3 years after end of recruitment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating tumor DNA', 'ctDNA diagnostics', 'Minimal residual disease'], 'conditions': ['Colorectal Cancer Stage III', 'Liver Metastasis Colon Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.guidemrd-horizon.eu/', 'label': 'Webpage of the GUIDE.MRD project'}]}, 'descriptionModule': {'briefSummary': "Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.\n\nThere is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.\n\nThe GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.\n\nGUIDE.MRD-01-CRC is a part of the GUIDE.MRD project.", 'detailedDescription': 'GUIDE.MRD-01-CRC is a part of WP3 of the overarching GUIDE.MRD project. Each study chair has a local clinical trial protocol where patients are recruited. After the end of recruitment, samples will be analyzed under the GUIDE.MRD consortium.\n\nThe overall aim of GUIDE.MRD is to investigate the clinical utility of ctDNA analysis to predict and guide the choice of multi-modal therapies prospectively. The fundamental steps towards this aim are assessment and benchmarking of the many available ctDNA diagnostics to identify the best-suited tests for clinical application. Clinical samples will be used to benchmark ctDNA diagnostics and assess their true clinical performance. The samples should reflect clinical situations where the ctDNA diagnostics are particularly useful, such as post-operatively, post-adjuvant, during chemotherapy, and longitudinally during post-treatment surveillance. In these situations, ctDNA diagnostics could be used to either monitor treatment response (in case of MRD after surgery) or to identify relapse at an early time point. Based on ctDNA information, medical treatment could be changed, or radiology could be used to reveal the location of residual disease.\n\nThe rationale for the observational clinical study GUIDE.MRD-01-CRC is to prospectively collect the clinical samples needed to enable assessment of the performance of ctDNA diagnostics in the setting of colorectal cancer (CRC). There are two main scenarios where ctDNA diagnostic is useful in CRC:\n\nStage III CRC (locally advanced, non-metastasized disease): This patient group is particularly relevant because adjuvant therapy is recommended for all stage III patients, due to their high recurrence risk, \\~25%. Nevertheless, most patients do not recur, and most of these do not need therapy at all, because they were already cured by surgery alone, which leads to substantial overtreatment. Furthermore, the 25% of patients who recur despite both surgery and adjuvant therapy, probably could benefit from further multimodal therapies. The challenge is, however, that currently there is no marker in clinical use that can identify those patients with residual disease and need for therapy. Circulating tumor DNA is potentially such a marker. However, currently, it is unknown, which, if any, of the many different ctDNA diagnostics developed in recent years have the required performance to provide clinical utility in the management of stage III CRC. This clinical dilemma will be addressed with the first cohort of GUIDE.MRD-01-CRC.\n\nMetastatic CRC with isolated liver metastases. Metastatic CRC with liver metastases is a unique tumor type in that surgical resection or complete ablation of the metastases, is the standard of care. In virtually all other tumor types, resection of liver metastases is considered only within clinical trials or in exceptional clinical circumstances. In contrast, resection, or ablation of colorectal cancer liver metastases (CRLM) are routinely performed with curative intention, and the overall 5-year survival is around 50%. Most relapses present within three years after operative intervention. The clinical benefit of adjuvant chemotherapy is currently a matter of debate, due to limited data from randomized controlled trials and recent results that indicate inferior overall survival (OS) in patients who received adjuvant therapy (JCOG0603). Based on these and earlier data (EORTC Trial 40983) that failed to show an OS benefit of adjuvant therapy after CRLM resection, it can be assumed that most patients are treated unnecessarily with chemotherapy, and those patients that could receive targeted agents are missed. No histological or clinical markers are available to guide decisions on adjuvant treatment. In this setting, ctDNA could be valuable to guide decisions on adjuvant chemotherapy (yes/no), the addition of biologicals such as anti-VEGF and anti-EGFR agents, targeted therapies in the case of BRAF mutations, or the presence of microsatellite instability (MSI), for example.\n\nPrimary objectives:\n\n* To assess the performance of ctDNA diagnostics using samples collected at the two-landmark time-points "post-surgery" and "post-adjuvant therapy". Sensitivity, specificity, and positive and negative predictive values of the ctDNA diagnostics will be determined to enable a head-to-head performance assessment and benchmarking of ctDNA diagnostics\n\nSecondary objectives\n\n* To assess the ctDNA stratified 3-year recurrence-free survival (RFS)\n* To assess the lead time between ctDNA detection and clinical recurrence\n* To assess the capacity of the ctDNA diagnostics to predict response to adjuvant therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Colorectal cancer stage III: patient with stage III colorectal cancer treated with curative-intent surgery and adjuvant chemotherapy\n\nColorectal cancer liver metastasis: patient with colorectal cancer liver metastasis', 'healthyVolunteers': False, 'eligibilityCriteria': "Colorectal cancer stage III\n\nInclusion Criteria:\n\n* Colorectal cancer, UICC stage III\n* Has received curative-intent resection and is a candidate for adjuvant chemotherapy\n* Patient able to understand and sign written informed consent\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome\n* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Verified distant metastases\n* Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included)\n* Treated with neoadjuvant chemo-radiation therapy\n* No tissue sample available for the project, or tumor content in the tissue sample is \\<20%\n* Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma)\n* Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening\n* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study\n\nColorectal cancer liver metastasis\n\nInclusion Criteria:\n\n* Colorectal cancer liver metastasis\n* Planned for curative-intent treatment\n* Performance status 0-1\n\nExclusion Criteria:\n\n* Liver cirrhosis\n* Extrahepatic metastases\n* Other cancer within the last 5 years\n* Intervention not performed with curative intent\n* No tissue available from CRLM or primary tumor"}, 'identificationModule': {'nctId': 'NCT06111105', 'briefTitle': 'GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing CtDNA Diagnostics - Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'GUIding Multi-moDal ThErapies Against MRD by Liquid Biopsies in Colorectal Cancer - GUIDE.MRD-01-CRC', 'orgStudyIdInfo': {'id': 'GUIDE.MRD-01-CRC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal cancer stage III'}, {'label': 'Colorectal cancer liver metastasis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Armin Gerger, MD, PhD', 'role': 'CONTACT', 'email': 'armin.gerger@medunigraz.at', 'phone': '+43-316-385-80625'}], 'facility': 'Abteilung für Onkologie, Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Felix Aigner, MD, PhD', 'role': 'CONTACT', 'email': 'Felix.Aigner@bbgraz.at', 'phone': '+43-316-7067-13002'}], 'facility': 'Ordenskrankenhaus Graz Mitte', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '2400', 'city': 'Copenhagen', 'state': 'Capital Region of Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Nis Hallundbæk Schlesinger', 'role': 'CONTACT', 'email': 'Nis.Hallundbaek.Schlesinger@regionh.dk'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'state': 'Capital Region of Denmark', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mads F Klein, MD, Ph.D', 'role': 'CONTACT', 'email': 'mads.falk.klein@regionh.dk'}, {'name': 'Jeppe Kildsig, MD', 'role': 'CONTACT', 'email': 'Jeppe.Kildsig@regionh.dk'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '8000', 'city': 'Aarhus', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lene H Iversen, MD, DMSc', 'role': 'CONTACT', 'email': 'lene.h.iversen@dadlnet.dk'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '7400', 'city': 'Herning', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Claudia Jaensch, MD, PhD', 'role': 'CONTACT', 'email': 'Claudia.Jaensch@goedstrup.rm.dk'}], 'facility': 'Gødstrup Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '8700', 'city': 'Horsens', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kåre A Gotschalck, MD, Ph.D', 'role': 'CONTACT', 'email': 'kaarsune@rm.dk'}], 'facility': 'Regional Hospital Horsens', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}, {'zip': '8930', 'city': 'Randers', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter Bondeven, MD, PhD', 'role': 'CONTACT', 'email': 'petefred@rm.dk'}], 'facility': 'Regional Hospital Randers', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}, {'zip': '8800', 'city': 'Viborg', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Uffe S Løve, MD, PhD', 'role': 'CONTACT', 'email': 'uffescho@rm.dk'}], 'facility': 'Regional Hospital Viborg', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '9000', 'city': 'Aalborg', 'state': 'North Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ole Thorlacius-Ussing, MD, PhD', 'role': 'CONTACT', 'email': 'otu@rn.dk'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '5000', 'city': 'Odense', 'state': 'The Region of Southern Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Per Vadgaard Andersen, MD, PhD', 'role': 'CONTACT', 'email': 'Per.vadgaard.andersen@rsyd.dk'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Alix-Panabiéres, PhD', 'role': 'CONTACT', 'email': 'c-panabieres@chu-montpellier.fr', 'phone': '+33 (0)4 11 75 99 31'}, {'name': 'Thomas Bardol, MD', 'role': 'CONTACT', 'email': 't-bardol@chu-montpellier.fr', 'phone': '+33 (0)4 11 75 99 31'}], 'facility': 'LCCRH (Laboratoire Cellules Circulantes Rares Humaines) - CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thilo Hackert, MD, MBA', 'role': 'CONTACT', 'email': 'allgemeinchirurgie@uke.de', 'phone': '+49 (0) 40 7410 - 52401'}, {'name': 'Nathaniel Melling, MD', 'role': 'CONTACT', 'email': 'n.melling@uke.de', 'phone': '+49 (0) 40 7410 - 50162'}], 'facility': 'Department of General-, Visceral- and Thoracic Surgery, University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel J Smit, MD, PhD', 'role': 'CONTACT', 'email': 'd.smit@uke.de', 'phone': '+49 (0) 40 7410 - 57495'}], 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '14183', 'city': 'Huddinge', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Marco Gerling, MD', 'role': 'CONTACT', 'email': 'marco.gerling@ki.se', 'phone': '0468-123 800 00'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}], 'centralContacts': [{'name': 'Claus L Andersen, PhD', 'role': 'CONTACT', 'email': 'cla@clin.au.dk', 'phone': '+45 7845 5319'}, {'name': 'Mads H Rasmussen, PhD', 'role': 'CONTACT', 'email': 'mads.heilskov@clin.au.dk', 'phone': '+45 7845 5314'}], 'overallOfficials': [{'name': 'Ellen Heitzer, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Graz'}, {'name': 'Klaus Pantel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}, {'name': 'Catherine Alix-Panabiéres, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Centre of Montpellier'}, {'name': 'Matthias Löhr, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Claus L Andersen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claus Lindbjerg Andersen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Graz', 'class': 'OTHER'}, {'name': 'University Medical Centre of Montpellier', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Claus Lindbjerg Andersen', 'investigatorAffiliation': 'University of Aarhus'}}}}