Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-29 @ 2:09 AM
Study NCT ID:
NCT06868095
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-12
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Center Study Protocol: Impact of Sarcopenia in Early-Onset Colorectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D055948', 'term': 'Sarcopenia'}], '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': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of sarcopenia on the incidence of EOCRC', 'timeFrame': 'Patients operated from 2000 to 2024 with at least 3 years follow-up', 'description': 'Evaluation of sarcopenia on the incidence of early-onset colorectal cancer'}], 'secondaryOutcomes': [{'measure': 'Overall survival in EOCRC patients', 'timeFrame': 'Patients operated from 2000 to 2024 with at least 3 years follow-up', 'description': 'Assessing the overall survival in patients with diagnosis of early-onset colorectal cancer'}, {'measure': 'Disease-free survival in EOCRC patients', 'timeFrame': 'Patients operated from 2000 to 2024 with at least 3 years follow-up', 'description': 'Assessing the disease-free survival in patients with diagnosis of early-onset colorectal cancer'}, {'measure': 'Prevalence of sarcopenia in EOCRC across different geographic regions', 'timeFrame': 'Patients operated from 2000 to 2024 with at least 3 years follow-up', 'description': 'Assess the prevalence of sarcopenia in patients with diagnosis of early-onset colorectal cancer according to different geographic regions, hence how different lifestyles and nutritional habits could impact the incidence of sarcopenia'}, {'measure': 'Impact of sarcopenia on post-operative complications.', 'timeFrame': 'Patients operated from 2000 to 2024 with at least 3 years follow-up', 'description': 'Investigate how sarcopenia influences post-operative complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Early Onset Colorectal Cancer', 'Sarcopenia', 'Prognostic Factors', 'Overall Survival', 'Disease-free Survival']}, 'referencesModule': {'references': [{'pmid': '32125769', 'type': 'BACKGROUND', 'citation': 'Weerink LBM, van der Hoorn A, van Leeuwen BL, de Bock GH. Low skeletal muscle mass and postoperative morbidity in surgical oncology: a systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):636-649. doi: 10.1002/jcsm.12529. Epub 2020 Mar 3.'}, {'pmid': '28124947', 'type': 'BACKGROUND', 'citation': 'Peterson SJ, Mozer M. Differentiating Sarcopenia and Cachexia Among Patients With Cancer. Nutr Clin Pract. 2017 Feb;32(1):30-39. doi: 10.1177/0884533616680354. Epub 2016 Dec 15.'}, {'pmid': '32224072', 'type': 'BACKGROUND', 'citation': 'Aro R, Makarainen-Uhlback E, Ammala N, Rautio T, Ohtonen P, Saarnio J, Merilainen S. The impact of sarcopenia and myosteatosis on postoperative outcomes and 5-year survival in curatively operated colorectal cancer patients - A retrospective register study. Eur J Surg Oncol. 2020 Sep;46(9):1656-1662. doi: 10.1016/j.ejso.2020.03.206. Epub 2020 Mar 17.'}, {'pmid': '38672612', 'type': 'BACKGROUND', 'citation': 'Roshandel G, Ghasemi-Kebria F, Malekzadeh R. Colorectal Cancer: Epidemiology, Risk Factors, and Prevention. Cancers (Basel). 2024 Apr 17;16(8):1530. doi: 10.3390/cancers16081530.'}]}, 'descriptionModule': {'briefSummary': "Sarcopenia's role in early-onset colorectal cancer (EOCRC), a subtype increasingly diagnosed in individuals under 50 years, has not yet been investigated according to recent literature.\n\nUnderstanding the prevalence and prognostic impact of sarcopenia in EOCRC could inform tailored therapeutic approaches and improve patient outcomes.", 'detailedDescription': "As reported by the GLOBOCAN study, EOCRC occurs in individuals younger than 50 years old. According to the GLOBOCAN estimates, there were 188,069 new cases of EOCRC, with an Age Standardized Incidence Rate (ASRs) of 2.9 per 100,000 person-years worldwide. Recent evidence suggested an increasing incidence rate for EOCRC in different populations, with greater changes in both developed and developing countries. Despite the declining trend in the incidence of CRC in the total population of the developed countries, the incidence rates for EOCRC were increasing both in the developed and developing world. Sarcopenia's role in early-onset colorectal cancer (EOCRC), a subtype increasingly diagnosed in individuals under 50 years, remains underexplored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients younger than 50 years old who underwent colorectal cancer resection, with histologically confirmed colorectal cancer (Histologically confirmed EOCRC) and with available baseline CT or MRI scans for sarcopenia assessment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed EOCRC\n* Emergency room access for suspected surgical pathology\n* Age: 18-49 years at diagnosis.\n* Available baseline CT or MRI scans for sarcopenia assessment\n\nExclusion Criteria:\n\n* Presence of comorbidity conditions severely affecting muscle mass unrelated to cancer (e.g., neuromuscular disorders).\n* Inadequate follow-up data or loss to follow-up\n* No past oncological history'}, 'identificationModule': {'nctId': 'NCT06868095', 'acronym': 'ISoPECC', 'briefTitle': 'Multi-Center Study Protocol: Impact of Sarcopenia in Early-Onset Colorectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Biomédica de Salamanca'}, 'officialTitle': 'Multi-Center Retrospective Study to Evaluate the Impact of Sarcopenia in Patients with Early-Onset Colorectal Cancer: Incidence Risk Factor or Negative Prognosis Predictor?', 'orgStudyIdInfo': {'id': 'ISoPECC Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'Patients \\< 50 years with diagnosis of colorectal cancer and with diagnosis of sarcopenia and CT-based assessment of skeletal muscle mass', 'interventionNames': ['Other: Surgical resection']}, {'label': 'Control group', 'description': 'patients \\<50 years who had a CT- scan for suspected appendicitis or any other abdominal surgical urgency'}], 'interventions': [{'name': 'Surgical resection', 'type': 'OTHER', 'description': 'Histologically confirmed EOCRC', 'armGroupLabels': ['Case group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Biomédica de Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}