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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03637569
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 69
• Patients Per Site Per Month: 14.5

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.
• Actual Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Apr 30, 2021
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Overall survival [through study completion, an average of 2 year]

   The duration between diagnosis and death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JooKyung Park, Assistant Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03637569
• Other Study ID Numbers: SMC 2018-04-087-001
• First Posted: Aug 20, 2018
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholangiocarcinoma; Pancreatic Neoplasms; Gallbladder Neoplasms

Study Results

No Results Posted as of Jan 26, 2021