Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT05923450
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Deposits in Colorectal Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079822', 'term': 'Extranodal Extension'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': '1 to 5 years overall survival'}, {'measure': 'Disease-free Survival', 'timeFrame': '5 years', 'description': '1 to 5 years disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tumor deposits', 'colorectal cancers', 'TNM staging system', 'ROC Curve'], 'conditions': ['Extranodal Extension']}, 'referencesModule': {'references': [{'pmid': '29112563', 'type': 'BACKGROUND', 'citation': 'Galizia G, Lieto E, Auricchio A, Cardella F, Mabilia A, Podzemny V, Castellano P, Orditura M, Napolitano V. Naples Prognostic Score, Based on Nutritional and Inflammatory Status, is an Independent Predictor of Long-term Outcome in Patients Undergoing Surgery for Colorectal Cancer. Dis Colon Rectum. 2017 Dec;60(12):1273-1284. doi: 10.1097/DCR.0000000000000961.'}, {'pmid': '36307056', 'type': 'RESULT', 'citation': 'Cervantes A, Adam R, Rosello S, Arnold D, Normanno N, Taieb J, Seligmann J, De Baere T, Osterlund P, Yoshino T, Martinelli E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Jan;34(1):10-32. doi: 10.1016/j.annonc.2022.10.003. Epub 2022 Oct 25. No abstract available.'}, {'pmid': '34954753', 'type': 'RESULT', 'citation': 'Pyo DH, Kim SH, Ha SY, Yun SH, Cho YB, Huh JW, Park YA, Shin JK, Lee WY, Kim HC. Revised Nodal Staging Integrating Tumor Deposit Counts With Positive Lymph Nodes in Patients With Stage III Colon Cancer. Ann Surg. 2023 Apr 1;277(4):e825-e831. doi: 10.1097/SLA.0000000000005355. Epub 2021 Dec 23.'}, {'pmid': '36790093', 'type': 'RESULT', 'citation': 'Khan H, Radomski SN, Siddiqi A, Zhou N, Paneitz DC, Johnston FM, Greer JB. Tumor deposits are associated with a higher risk of peritoneal disease in non-metastatic colorectal cancer patients. J Surg Oncol. 2023 May;127(6):975-982. doi: 10.1002/jso.27207. Epub 2023 Feb 15.'}, {'pmid': '38353074', 'type': 'DERIVED', 'citation': 'Lieto E, Auricchio A, Ronchi A, Del Sorbo G, Panarese I, Ferraraccio F, De Vita F, Galizia G, Cardella F. Presence of tumor deposits is a strong indicator of poor outcome in patients with stage III colorectal cancers undergoing radical surgery. J Gastrointest Surg. 2024 Jan;28(1):47-56. doi: 10.1016/j.gassur.2023.11.003.'}]}, 'descriptionModule': {'briefSummary': 'Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. The Authors propose a new staging system to optimize treatments.', 'detailedDescription': 'Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs).In the current staging system TDs are somewhat neglected.\n\nIt has been proposed to add TD count to the number of metastatic lymph nodes or to consider TDs as distant metastases, but the scientific basis of these proposals seems dubious and not supported by robust statistical analyses.\n\nThe investigators supposed that splitting the three sub-stages of the stage III CRC according to absence or presence of TDs could be an easy and useful method to avoid the loss of crucial information. The proposed study will include 243 stage III CRC patients undergoing radical surgery and adjuvant chemotherapy. Each new substage, according to absence or presence of tumor deposits, will be analyzed with sophisticated statistical analysis (particularly the area-under-curve (AUC), calculated by the time-dependent receiver-operating-characteristic (ROC) curve for censored survival data) to individuate if this new staging does better the current one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'colorectal cancer patients with metastatic nodes undergoing radical surgery and adjuvant chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy\n\nExclusion Criteria:\n\n* Lynch syndrome\n* Rectal Cancer undergoing neoadjuvant (radio)chemotherapy\n* colorectal cancers without metastatic nodes\n* metastatic colorectal cancers\n* eligible patients refusing adjuvant chemotherapy'}, 'identificationModule': {'nctId': 'NCT05923450', 'acronym': 'TD', 'briefTitle': 'Tumor Deposits in Colorectal Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Presence of Tumor Deposits is a Strong Indicator of Poor Outcome in Stage III Colorectal Cancers Undergoing Radical Surgery: Need for an Urgent Revision of the Staging System', 'orgStudyIdInfo': {'id': 'Vanvitelli Naples'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tumor Deposits', 'description': 'Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy', 'interventionNames': ['Procedure: Colorectal Resection']}], 'interventions': [{'name': 'Colorectal Resection', 'type': 'PROCEDURE', 'description': 'Radical resection of colorectal cancer', 'armGroupLabels': ['Tumor Deposits']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gennaro Galizia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Campania 'Luigi Vanvitelli'"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'one month after publication', 'ipdSharing': 'YES', 'description': 'all data will be shared after publication', 'accessCriteria': 'email to gennaro.galizia@unicampania.it'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Surgery', 'investigatorFullName': 'Gennaro Galizia', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}