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The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer

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ClinicalTrials.gov Identifier: NCT03637569
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
JooKyung Park, Samsung Medical Center

Tracking Information
First Submitted Date July 26, 2018
First Posted Date August 20, 2018
Last Update Posted Date August 20, 2018
Actual Study Start Date April 1, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 16, 2018)
Overall survival [ Time Frame: through study completion, an average of 2 year ]
The duration between diagnosis and death
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer
Official Title The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.
Brief Summary In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.
Detailed Description 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who visit and treated at Samsung medical center.
Condition
  • Pancreas Cancer
  • Cholangiocarcinoma
  • Gallbladder Cancer
Intervention Other: Measurement of triceps skinfold thickness
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.
Study Groups/Cohorts Cancer patients
Newly diagnosed pancreatic, bile duct or GB cancer patients at samsung medical center.
Intervention: Other: Measurement of triceps skinfold thickness
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 16, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2022
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care).
  • Age above 18 years old

Exclusion Criteria:

  • Other malignant disease
  • Underlying intestinal disease that cause absorprtion disorder
  • Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sang-geul Lee, M.D. 8201089583929 sg3929.lee@samsung.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03637569
Other Study ID Numbers SMC 2018-04-087-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party JooKyung Park, Samsung Medical Center
Study Sponsor Samsung Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Samsung Medical Center
Verification Date August 2018