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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03172403
Acronym
MYOCAC
Enrollment
3
Registered
2017-06-01
Start date
2018-08-02
Completion date
2019-08-01
Last updated
2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Digestive System

Keywords

Cachexia, Cancer of Digestive System, Myostatin, Skeletal muscle

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.

Interventions

DIAGNOSTIC_TESTHeight and weight

Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1)

DIAGNOSTIC_TESTBlood 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_TESTSkeletal 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_TESTSkeletal 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_TESTMuscle biopsy

Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between skeletal muscle and degree myostatinDay 1Evaluate 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

MeasureTime frameDescription
Correlation between skeletal muscle force and index before resection surgeryBaseline from 7 monthsEvaluate 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 myostatinMonth 2Evaluate 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 surgeryMonth 2Determinate 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 resultsMonth 2Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026