Pancreas CancerNCT03637569
The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer
An observational study of Pancreas Cancer and Cholangiocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Cholangiocarcinoma, Gallbladder Cancer
- What is being tested?
- Measurement of triceps skinfold thickness
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2018to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit and treated at Samsung medical center.
Who may be able to join
- Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care).
- Age above 18 years old
Who cannot join
- Other malignant disease
- Underlying intestinal disease that cause absorprtion disorder
- Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Joo Kyung Park, MD, 82-2-3410-3409, mdsophie@gmail.com
About this study
Official title: The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.
In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.
Read the 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.
- Conditions
- Pancreas Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Being tested
- Measurement of triceps skinfold thickness
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of triceps skinfold thicknessOther
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 group | Role | What they receive |
|---|---|---|
| Cancer patients | Newly diagnosed pancreatic, bile duct or GB cancer patients at samsung medical center. Receives: Other: Measurement of triceps skinfold thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The duration between diagnosis and death
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Apr 2018
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JooKyung Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637569
- Sponsor's protocol ID
- SMC 2018-04-087-001
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2018
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.
- ClinicalTrials.gov ID
- NCT03637569
- Acronym / sponsor ID
- SMC 2018-04-087-001
- Conditions
- Pancreas Cancer, Cholangiocarcinoma, Gallbladder Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Other: Measurement of triceps skinfold thicknessNewly diagnosed pancreatic, bile duct or GB cancer patients at samsung medical center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit and treated at Samsung medical center.
Key inclusion criteria (2 listed)
- Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care).
- Age above 18 years old
Key exclusion criteria (3 listed)
- Other malignant disease
- Underlying intestinal disease that cause absorprtion disorder
- Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of triceps skinfold thicknessBy 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. | Other | Cancer patients |
Primary outcome
Overall survival
Time frame: through study completion, an average of 2 year
The duration between diagnosis and death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Cholangiocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong-In Chnag, M.D. (82-2-3410-3409, ji.chang@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.