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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

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.

Condition or disease Intervention/treatment
Pancreas Cancer Cholangiocarcinoma Gallbladder Cancer Other: Measurement of triceps skinfold thickness

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2022


Group/Cohort Intervention/treatment
Cancer patients
Newly diagnosed pancreatic, bile duct or GB cancer patients at samsung medical center.
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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: through study completion, an average of 2 year ]
    The duration between diagnosis and death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who visit and treated at Samsung medical center.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637569


Contacts
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Contact: Sang-geul Lee, M.D. 8201089583929 sg3929.lee@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joo Kyung Park, MD    82-2-3410-3409    mdsophie@gmail.com   
Sponsors and Collaborators
Samsung Medical Center

Additional Information:

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Responsible Party: JooKyung Park, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03637569     History of Changes
Other Study ID Numbers: SMC 2018-04-087-001
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gallbladder Neoplasms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Endocrine System Diseases