Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-26 @ 7:30 AM
Study NCT ID:
NCT06044961
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2023-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of radiomics', 'timeFrame': '1 month', 'description': 'Apply radiomics for predicting response to neoadjuvant therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stomach cancer', 'esophagogastric junction.', 'locally advanced carcinoma of the stomach', 'radiomics'], 'conditions': ['Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric Junction']}, 'descriptionModule': {'briefSummary': 'Identifying predictors of response to neoadjuvant therapy in gastric and gastro-oesophageal cancer early in the history of the disease would ensure optimal treatment planning.\n\nThe study aims to apply radiomics for the prediction of response to neoadjuvant therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced stomach cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with locally advanced stomach cancer undergoing neoadjuvant chemotherapy and gastrectomy between January 2005 and August 2022\n\nExclusion Criteria:\n\n* Siewert 1 tumors;\n* Patients who have received neoadjuvant with the addition of a biological drug;\n* Patients who have received radiotherapy;\n* Patients without staging CT scan or with insufficient image quality in terms of phases performed, pixel spacing, slide thickness (mandatorily: \\> 5 mm) or artefacts.'}, 'identificationModule': {'nctId': 'NCT06044961', 'acronym': 'RADI-S', 'briefTitle': 'Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Radiomics-based Models for the Prediction of Pathological Response to Neoadjuvant Therapy in Gastric and Gastroesophageal Cancer', 'orgStudyIdInfo': {'id': '5297'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT scan', 'type': 'RADIATION', 'description': 'All pre-operative CT scan collected'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Agnes Annamaria', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}