Trials / Terminated
TerminatedNCT03172403
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)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Height and weight | Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1) |
| DIAGNOSTIC_TEST | Blood samples | 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) |
| DIAGNOSTIC_TEST | Skeletal muscle force | 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) |
| DIAGNOSTIC_TEST | Skeletal muscle index | 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) |
| DIAGNOSTIC_TEST | Muscle biopsy | Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2) |
Timeline
- Start date
- 2018-08-02
- Primary completion
- 2019-01-03
- Completion
- 2019-08-01
- First posted
- 2017-06-01
- Last updated
- 2022-08-25
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03172403. Inclusion in this directory is not an endorsement.