Clinical trial · Interventional
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped prematurely by decision of the sponsor due to lack of inclusion.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Digestive System | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples | Diagnostic Test | — | UNRESOLVED |
| Height and weight | Diagnostic Test | — | UNRESOLVED |
| Muscle biopsy | Diagnostic Test | — | UNRESOLVED |
| Skeletal muscle force | Diagnostic Test | — | UNRESOLVED |
| Skeletal muscle index | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with digestive cancer requiring resection surgery
- 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
- interventionNames
- Diagnostic Test: Height and weight
- Diagnostic Test: Blood samples
- Diagnostic Test: Skeletal muscle force
- Diagnostic Test: Skeletal muscle index
- Diagnostic Test: Muscle biopsy
Primary outcomes (1)
- measure
- Correlation between skeletal muscle and degree myostatin
- timeFrame
- Day 1
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available