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Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia (MYOCAC)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Cancer of Digestive System

Treatments

Diagnostic Test: Blood samples
Diagnostic Test: Height and weight
Diagnostic Test: Muscle biopsy
Diagnostic Test: Skeletal muscle index
Diagnostic Test: Skeletal muscle force

Study type

Interventional

Funder types

Other

Identifiers

NCT03172403
1708054
ANSM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Patients with digestive cancer requiring resection surgery
Experimental group
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
Treatment:
Diagnostic Test: Muscle biopsy
Diagnostic Test: Skeletal muscle index
Diagnostic Test: Height and weight
Diagnostic Test: Blood samples
Diagnostic Test: Skeletal muscle force

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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