Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04576858
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to recurrence', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': '1 year'}, {'measure': 'Overall survival', 'timeFrame': '5 year'}, {'measure': 'Response rate RECIST 1.1', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Response duration RECIST 1.1', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating Tumor DNA'], 'conditions': ['Esophageal Cancer', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for\n\n* Surgical resection + perioperative chemotherapy (cohort 1)\n* Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2)\n* Definitive chemoradiotherapy with curative intent (cohort 3)\n* Systemic therapy with the intent to prolong survival (cohort 4)\n* Palliative treatment without the use of chemotherapy (cohort 5)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes patients with gastroesophageal cancer in five prospective cohorts. Neither WGS/WES on primary tumor nor serial blood samples for ctDNA are mandatory for inclusion in the study. However, it is highly encouraged to perform WGS/WES of the primary tumor. A retrospective cohort will be open for inclusion to facilitate initial hypothesis testing to be validated in the prospective cohorts', 'eligibilityCriteria': 'Inclusion Criteria:\n\nGastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent\n\nExclusion Criteria:\n\nPatients not providing informed consent'}, 'identificationModule': {'nctId': 'NCT04576858', 'acronym': 'CURE', 'briefTitle': 'Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer', 'orgStudyIdInfo': {'id': 'CURE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: Surgical resection + perioperative chemotherapy', 'interventionNames': ['Diagnostic Test: Circulating tumor DNA']}, {'label': 'Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery', 'interventionNames': ['Diagnostic Test: Circulating tumor DNA']}, {'label': 'Cohort 3: Definitive chemoradiotherapy', 'interventionNames': ['Diagnostic Test: Circulating tumor DNA']}, {'label': 'Cohort 4: Chemotherapy with the aim to prolong life expectancy', 'interventionNames': ['Diagnostic Test: Circulating tumor DNA']}, {'label': 'Cohort 5: Non-chemotherapeutic palliation', 'description': 'E.g. Palliative radiotherapy'}], 'interventions': [{'name': 'Circulating tumor DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of circulating tumor DNA from plasma over a period of 2 years.', 'armGroupLabels': ['Cohort 1: Surgical resection + perioperative chemotherapy', 'Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery', 'Cohort 3: Definitive chemoradiotherapy', 'Cohort 4: Chemotherapy with the aim to prolong life expectancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Mau-Sørensen, MD, PhD', 'role': 'CONTACT', 'email': 'morten.mau-soerensen@regionh.dk', 'phone': '35450879', 'phoneExt': '0045'}, {'name': 'Lene Baeksgaard', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Achiam', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rajendra S Garbyal', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Olga Oestrup', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mette Siemsen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Morten Thorsteinsson', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Camilla Qvortrup', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jane P Hasselby', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lise B Ahlborn', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Morten Mau-Sørensen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Morten Mau-Sørensen, MD, PhD', 'role': 'CONTACT', 'email': 'mms@rh.regionh.dk', 'phone': '35450879', 'phoneExt': '0045'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician, MD, PhD', 'investigatorFullName': 'Morten Mau-Sørensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}