Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT03637569
Status:
RECRUITING
Last Update Posted:
2023-08-25
First Post:
2018-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'The duration between diagnosis and death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Cancer', 'Cholangiocarcinoma', 'Gallbladder Cancer']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.', 'detailedDescription': 'Cachexia is frequently seen in pancreatic cancer(70-80%) and associated with reduced survival, reduced treatment tolerance and reduction in QoL. In recent studies, low-normal BMI have worse outcome (overall mortality) in cardiovascular, malignant, chronic disease (So called "obesity paradox") BMI is simple method but hard to define body composition because BMI is based on only weight and height. Skinfold thickness is strongly associated with body fatness than BMI. In this study, the ivestigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who visit and treated at Samsung medical center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care).\n* Age above 18 years old\n\nExclusion Criteria:\n\n* Other malignant disease\n* Underlying intestinal disease that cause absorprtion disorder\n* Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)'}, 'identificationModule': {'nctId': 'NCT03637569', 'briefTitle': 'The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.', 'orgStudyIdInfo': {'id': 'SMC 2018-04-087-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer patients', 'description': 'Newly diagnosed pancreatic, bile duct or GB cancer patients at samsung medical center.', 'interventionNames': ['Other: Measurement of triceps skinfold thickness']}], 'interventions': [{'name': 'Measurement of triceps skinfold thickness', 'type': 'OTHER', 'description': 'By using skin thickness caliper, measure triceps skinfold thickness on the half of forearm (Rt side). In every 3 weeks, triceps skinfold thickness will be measured.', 'armGroupLabels': ['Cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo Kyung Park, MD', 'role': 'CONTACT', 'email': 'mdsophie@gmail.com', 'phone': '82-2-3410-3409'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jong-In Chnag, M.D.', 'role': 'CONTACT', 'email': 'ji.chang@samsung.com', 'phone': '82-2-3410-3409'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'JooKyung Park', 'investigatorAffiliation': 'Samsung Medical Center'}}}}