Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-25 @ 8:46 PM
Study NCT ID:
NCT02901132
Status:
UNKNOWN
Last Update Posted:
2017-04-11
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples of abdominal rectal muscles.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-09', 'studyFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'mtor signaling pathway', 'timeFrame': 'December, 2016', 'description': 'mTOR Elisa kits'}], 'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'August, 2016', 'description': 'According to the Dindo-Clavien protocol'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'July, 2016', 'description': 'Follow up using medical records and telephone contacts'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Postoperative Complications', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '28918167', 'type': 'DERIVED', 'citation': 'Mauricio SF, Xiao J, Prado CM, Gonzalez MC, Correia MITD. Different nutritional assessment tools as predictors of postoperative complications in patients undergoing colorectal cancer resection. Clin Nutr. 2018 Oct;37(5):1505-1511. doi: 10.1016/j.clnu.2017.08.026. Epub 2017 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. The etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. The objective of this study is to investigate the association and prognostic value of five distinct methods of nutritional assessment (molecular, body composition, functional, anthropometric and subjective) in relation to postoperative complications and short-term survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of the operation. Body composition was assessed by computed tomography (CT) and bioelectrical impedance test was conducted to evaluate the phase angle. Handgrip strength was used to determine functionality. The percentage of weight loss in relation to usual weight was the anthropometric parameter used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis. Postoperative complications were classified according to the Dindo and Clavien classification. Overall time survival was the period between the first assessment of the patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and the Log Rank test and regression analysis will be used (p \\<0.05).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients that will be submitted a surgical treatment at University Hospital of University Federal of Minas Gerais.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic cancer confirmed\n* Over 18 years old\n* Accepted the terms of survey\n\nExclusion Criteria:\n\n* Tumor synchronic\n* Inflamattory disease\n* Under 18 years old\n* No accepted the terms of survey'}, 'identificationModule': {'nctId': 'NCT02901132', 'briefTitle': 'Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients', 'orgStudyIdInfo': {'id': 'FUMinas Gerais'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer group 1', 'description': 'Colorectal cancer patients, under 18 years old, no inflammatory disease, weight loss greater 10% habitual body weight, sarcopenic.'}, {'label': 'Control group', 'description': 'No cancer patients, under 18 years old, no inflammatory disease, no weight loss, no sarcopenic.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30640100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'UFMG Hospital', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital of Clinics of the University Federal of Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Scientific publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Maria Isabel Toulson Davisson Correia', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}