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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2017-A01233-50 |
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The study was stopped prematurely by decision of the sponsor due to lack of inclusion.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with digestive cancer requiring resection surgery | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Height and weight | Diagnostic Test | Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline from 7 months |
| Correlation between level of myostatin muscular expression and degree myostatin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karine ABBOUD, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D015431 | Weight Loss |
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| ID | Term |
|---|---|
| D001827 | Body Height |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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| Blood samples | Diagnostic Test | 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) |
|
| Skeletal muscle force | Diagnostic Test | 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) |
|
| Skeletal muscle index | Diagnostic Test | 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) |
|
| Muscle biopsy | Diagnostic Test | Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2) |
|
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. |
| Month 2 |
| 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. | Month 2 |
| 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. | Month 4 |
| 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. | Month 7 |
| 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. | Month 2 |
| D001836 |
| Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000067029 | Physical Appearance, Body |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
| D006128 | Growth |
| D048788 | Growth and Development |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |