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

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ClinicalTrials.gov Identifier: NCT03172403
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Cancer of Digestive System Diagnostic Test: Height and weight Diagnostic Test: Blood samples Diagnostic Test: Skeletal muscle force Diagnostic Test: Skeletal muscle index Diagnostic Test: Muscle biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: Patients with digestive cancer requiring resection surgery

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

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)




Primary Outcome Measures :
  1. Correlation between skeletal muscle and degree myostatin [ Time Frame: Day 1 ]

    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.



Secondary Outcome Measures :
  1. Correlation between skeletal muscle force and index before resection surgery [ Time Frame: Baseline from 7 months ]
    Evaluate Correlation between skeletal muscle force and index before resection surgery to estimate the extent of cachexia-induced muscle dysfunction by results tests.

  2. Correlation between level of myostatin muscular expression and degree myostatin [ Time Frame: Month 2 ]

    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.


  3. Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery [ Time Frame: Month 2 ]
    Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.

  4. Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery [ Time Frame: Month 4 ]
    Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.

  5. Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery [ Time Frame: Month 7 ]
    Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.

  6. Analysis level of myostatin muscular expression and blood samples results [ Time Frame: Month 2 ]
    Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172403


Contacts
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Contact: Karine ABBOUD, MD (0)477828337 ext +33 Karine.abboud@chu-st-etienne.fr
Contact: Florence RANCON, CRA (0)477829458 ext +33 florence.rancon@chu-st-etienne.fr

Locations
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France
CHU Saint-Etienne Recruiting
Saint-Étienne, France, 42055
Principal Investigator: Karine ABBOUD, MD         
Sub-Investigator: Olivier TIFFET, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Karine ABBOUD, MD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03172403     History of Changes
Other Study ID Numbers: 1708054
ANSM ( Other Identifier: 2017-A01233-50 )
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Cachexia
Cancer of Digestive System
Myostatin
Skeletal muscle
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Wasting Syndrome
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Neoplasms by Site
Neoplasms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs