Skeletal Muscle RadiodensityNCT05584852
Prognostic Value of Myosteatosis and Creatinine-to-cystatin C Ratio in Patients With Pancreatic Ductal Adenocarcinoma
An observational study of Skeletal Muscle Radiodensity and Myosteatosis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) is a dismal disease with a 5-year survival rate as low as 6%. It causes body composition changes and many patients develop muscle loss with disease progression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Skeletal Muscle Radiodensity, Myosteatosis, Scr/CysC Ratio
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study enrolled patients who underwent surgery for resectable pancreatic ductal adenocarcinoma, from January 2016 to December 2021. Patients will be divided into myosteatosis and non-myosteatosis groups according to skeletal muscle radiodensity.
Who may be able to join
- a） aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.
Who cannot join
- ① pancreatic malignant tumors of other pathological types or other malignant tumors;
- received local or systemic radiotherapy and chemotherapy before operation;
- with severe metabolic diseases such as decompensated cirrhosis, nervous system diseases and muscle degenerative diseases; ④ absent of preoperative imaging or clinical data; ⑤ Lost interviewers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Affiliated Hospital of Qingdao University
Qingdao, Shandong
Xue Jing, 18661807575, jingxue@qdu.edu.cn
Shenghua Bi, 18863608195, bsh112359@163.com
About this study
Official title: Prognostic Value of Myosteatosis and Creatinine-to-cystatin C Ratio in Patients With Resectable Pancreatic Ductal Adenocarcinoma
Pancreatic ductal adenocarcinoma (PDAC) is a dismal disease with a 5-year survival rate as low as 6%. It causes body composition changes and many patients develop muscle loss with disease progression. Computed tomography (CT) is a common, noninvasive method of muscle assessment.Known as myoesteatosis,low muscle radiodensity is reflective of intermuscular adipose tissue that influences survival outcomes in patients with cancer.Serum creatinine (Scr) and cystatin C (CysC) are usually employed to estimate renal function in clinical practice. Scr is a metabolic waste product produced by creatine in skeletal muscle. CysC can be produced by all nucleated cells in the body at a constant production rate. CysC is used as an endogenous marker to reflect the glomerular filtration rate. Some studies have supported that the Scr/CysC ratio (CCR) is a simple and inexpensive measure that can be used to evaluate the skeletal muscle mass of patients with malignancies, such as gastric cancer. Therefore, the purpose of the present study is to explore the association between CCR and myosteatosis upon diagnosis of PDAC, specially whether the co-occurrence of these factors could predict survival outcomes.Preoperative assessment of muscle quality may be valuable for treatment planning and optimization of nutritional support.
This retrospective study enrolls patients who underwent surgery for PDAC, from January 2016 to December 2021. Patients will be divided into myosteatosis and non-myosteatosis groups. Clinical and imaging data are collected.The study does not have any intervention measures and harm to subjects.
Read the detailed description
Inclusion criteria:
a）aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.
Exclusion criteria:
- pancreatic malignant tumors of other pathological types or other malignant tumors;
- received local or systemic radiotherapy and chemotherapy before operation; ③ with severe metabolic diseases such as decompensated cirrhosis, nervous system diseases and muscle degenerative diseases; ④ absent of preoperative imaging or clinical data;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
no intervention
| Study group | Role | What they receive |
|---|---|---|
| with myosteatosis | Not described | |
| without myosteatosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Time from operation to death or the last follow-up
Measured: 2016.1.1-2022.12.31
Disease free survival
Time from operation to recurrence or the last follow-up
Measured: 2016.1.1-2022.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle RadiodensityStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jingxue, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584852
- Sponsor's protocol ID
- QYFYWZLL27348
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2022
- Last updated
- 8 Nov 2022
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Myosteatosis and Creatinine-to-cystatin C Ratio in Patients With Resectable Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05584852
- Acronym / sponsor ID
- QYFYWZLL27348
- Conditions
- Skeletal Muscle Radiodensity, Myosteatosis, Scr/CysC Ratio, Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 18 Oct 2022 (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.
Pancreatic ductal adenocarcinoma (PDAC) is a dismal disease with a 5-year survival rate as low as 6%. It causes body composition changes and many patients develop muscle loss with disease progression. Computed tomography (CT) is a common, noninvasive method of muscle assessment.Known as myoesteatosis,low muscle radiodensity is reflective of intermuscular adipose tissue that influences survival outcomes in patients with cancer.Serum creatinine (Scr) and cystatin C (CysC) are usually employed to estimate renal function in clinical practice. Scr is a metabolic waste product produced by creatine in skeletal muscle. CysC can be produced by all nucleated cells in the body at a constant production rate. CysC is used as an endogenous marker to reflect the glomerular filtration rate. Some studies have supported that the Scr/CysC ratio (CCR) is a simple and inexpensive measure that can be used to evaluate the skeletal muscle mass of patients with malignancies, such as gastric cancer. Therefore, the purpose of the present study is to explore the association between CCR and myosteatosis upon diagnosis of PDAC, specially whether the co-occurrence of these factors could predict survival outcomes.Preoperative assessment of muscle quality may be valuable for treatment planning and optimization of nutritional support.
This retrospective study enrolls patients who underwent surgery for PDAC, from January 2016 to December 2021. Patients will be divided into myosteatosis and non-myosteatosis groups. Clinical and imaging data are collected.The study does not have any intervention measures and harm to subjects.
Detailed description
Inclusion criteria:
a）aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.
Exclusion criteria:
- pancreatic malignant tumors of other pathological types or other malignant tumors;
- received local or systemic radiotherapy and chemotherapy before operation; ③ with severe metabolic diseases such as decompensated cirrhosis, nervous system diseases and muscle degenerative diseases; ④ absent of preoperative imaging or clinical data;
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with myosteatosis | – | – |
| without myosteatosis | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study enrolled patients who underwent surgery for resectable pancreatic ductal adenocarcinoma, from January 2016 to December 2021. Patients will be divided into myosteatosis and non-myosteatosis groups according to skeletal muscle radiodensity.
Key inclusion criteria (1 listed)
- a） aged between 18 and 75; b) pancreatic ductal adenocarcinoma confirmed by biopsy or postoperative pathology; c) CT and renal function related data within 1 month before operation; d) voluntarily participate in this study and have informed consent.
Key exclusion criteria (3 listed)
- ① pancreatic malignant tumors of other pathological types or other malignant tumors;
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 |
|---|---|---|
| no intervention | Other | with myosteatosis, without myosteatosis |
Primary outcome
overall survival
Time frame: 2016.1.1-2022.12.31
Time from operation to death or the last follow-up
Disease free survival
Time frame: 2016.1.1-2022.12.31
Time from operation to recurrence or the last follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
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 Skeletal Muscle Radiodensity and Myosteatosis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2016.1.1-2022.12.31). The study lists 2 primary outcomes in all. 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 8 Nov 2022.