Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia (MYOCAC)
Primary Purpose
Cancer of Digestive System
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Height and weight
Blood samples
Skeletal muscle force
Skeletal muscle index
Muscle biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Cancer of Digestive System focused on measuring Cachexia, Cancer of Digestive System, Myostatin, Skeletal muscle
Eligibility Criteria
Inclusion Criteria:
- Women and men aged 40-80.
- Diagnosis for cancer of digestive system requiring surgery with neoadjuvant treatment or not.
- Signature of consent
- Affiliate or beneficiary of social security
Exclusion Criteria:
- Administration of corticosteroids.
- Thyroid disease treated.
- Severe chronic pathology during treatment (neuro-muscular pathologies, renal insufficiency requiring dialysis, COPD under continuous oxygen therapy).
- Psychological, familial, social or geographical conditions that could affect the participation of the subject throughout the duration of the protocol.
- BMI> 30 due to the difficulty of interpretation of BMI variations in obese patients
Sites / Locations
- CHU Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with digestive cancer requiring resection surgery
Arm Description
Patients with cancer of digestive system requiring resection surgery will be included. They will have measure of height and weight, blood samples, skeletal muscle force, skeletal muscle index and muscle biopsy. V1: Inclusion will be effectuated at the time of anaesthetic consultation V2: The day before and day of resection surgery about 1 month after V3: Follow-up at 1 month V4: Follow-up at 3 months V6: Follow-up at 6 months
Outcomes
Primary Outcome Measures
Correlation between skeletal muscle and degree myostatin
Evaluate correlation between skeletal muscle force/index and degree myostatin. Skeletal muscle force/index will be determinated by skeletal muscle force/index results.
Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.
Secondary Outcome Measures
Correlation between skeletal muscle force and index before resection surgery
Evaluate Correlation between skeletal muscle force and index before resection surgery to estimate the extent of cachexia-induced muscle dysfunction by results tests.
Correlation between level of myostatin muscular expression and degree myostatin
Evaluate correlation between level of myostatin muscular expression and degree myostatin.
Level of myostatin muscular expression will be determinated by muscle biopsy. Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.
Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.
Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.
Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.
Analysis level of myostatin muscular expression and blood samples results
Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.
Full Information
NCT ID
NCT03172403
First Posted
May 23, 2017
Last Updated
August 22, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT03172403
Brief Title
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia
Acronym
MYOCAC
Official Title
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped prematurely by decision of the sponsor due to lack of inclusion.
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
January 3, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Digestive System
Keywords
Cachexia, Cancer of Digestive System, Myostatin, Skeletal muscle
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with digestive cancer requiring resection surgery
Arm Type
Experimental
Arm Description
Patients with cancer of digestive system requiring resection surgery will be included. They will have measure of height and weight, blood samples, skeletal muscle force, skeletal muscle index and muscle biopsy.
V1: Inclusion will be effectuated at the time of anaesthetic consultation V2: The day before and day of resection surgery about 1 month after V3: Follow-up at 1 month V4: Follow-up at 3 months V6: Follow-up at 6 months
Intervention Type
Diagnostic Test
Intervention Name(s)
Height and weight
Intervention Description
Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1)
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood samples
Intervention Description
Blood samples will be collected for measuring myostatin on blood at the time of anaesthetic consultation, the day before resection surgery, follow-ups at 1, 3 and 6 months. (V1, V2, V3, V4, V6)
Intervention Type
Diagnostic Test
Intervention Name(s)
Skeletal muscle force
Intervention Description
Skeletal muscle force will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)
Intervention Type
Diagnostic Test
Intervention Name(s)
Skeletal muscle index
Intervention Description
Skeletal muscle index will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)
Intervention Type
Diagnostic Test
Intervention Name(s)
Muscle biopsy
Intervention Description
Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)
Primary Outcome Measure Information:
Title
Correlation between skeletal muscle and degree myostatin
Description
Evaluate correlation between skeletal muscle force/index and degree myostatin. Skeletal muscle force/index will be determinated by skeletal muscle force/index results.
Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Correlation between skeletal muscle force and index before resection surgery
Description
Evaluate Correlation between skeletal muscle force and index before resection surgery to estimate the extent of cachexia-induced muscle dysfunction by results tests.
Time Frame
Baseline from 7 months
Title
Correlation between level of myostatin muscular expression and degree myostatin
Description
Evaluate correlation between level of myostatin muscular expression and degree myostatin.
Level of myostatin muscular expression will be determinated by muscle biopsy. Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.
Time Frame
Month 2
Title
Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
Description
Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.
Time Frame
Month 2
Title
Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
Description
Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.
Time Frame
Month 4
Title
Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
Description
Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.
Time Frame
Month 7
Title
Analysis level of myostatin muscular expression and blood samples results
Description
Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.
Time Frame
Month 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women and men aged 40-80.
Diagnosis for cancer of digestive system requiring surgery with neoadjuvant treatment or not.
Signature of consent
Affiliate or beneficiary of social security
Exclusion Criteria:
Administration of corticosteroids.
Thyroid disease treated.
Severe chronic pathology during treatment (neuro-muscular pathologies, renal insufficiency requiring dialysis, COPD under continuous oxygen therapy).
Psychological, familial, social or geographical conditions that could affect the participation of the subject throughout the duration of the protocol.
BMI> 30 due to the difficulty of interpretation of BMI variations in obese patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine ABBOUD, MD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia
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