Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-02-25 @ 7:08 PM
Study NCT ID:
NCT04538404
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2020-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality Score in Elderly Patients With Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2020-08-22', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population', 'timeFrame': 'Up to 30 days after surgery', 'description': 'MEC Score (arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine) for the evaluation of the risk of in-hospital mortality occurred during hospitalization up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colon cancer', 'surgery', 'mortality', 'elderly', 'scoring system'], 'conditions': ['Mortality', 'Surgery', 'Colon Cancer']}, 'descriptionModule': {'briefSummary': 'CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.', 'detailedDescription': 'Patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an Italian hospital were retrospectively selected. MECC score \\[Mortality in Elderly patients with Colon Cancer\\] was calculated summing up the scores relating to: arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine. Once CR-POSSUM was calculated, the two scores were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches\n\nExclusion Criteria:\n\n* Surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies'}, 'identificationModule': {'nctId': 'NCT04538404', 'acronym': 'MECC', 'briefTitle': 'Mortality Score in Elderly Patients With Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Score for the Prediction of Mortality Risk After Surgery for Colon Cancer in a Case Series of Elderly Patients', 'orgStudyIdInfo': {'id': 'MECC Score'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colon Surgery', 'type': 'PROCEDURE', 'description': 'Right, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Bruno Nardo', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Marialuisa Lugaresi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Bruno Nardo, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor MD, PhD', 'investigatorFullName': 'Marialuisa Lugaresi', 'investigatorAffiliation': 'University of Bologna'}}}}