Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia

NCT ID: NCT03172403

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2019-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer of Digestive System

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Height and weight

Intervention Type DIAGNOSTIC_TEST

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

Blood samples

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Height and weight

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

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Muscle biopsy

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karine ABBOUD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1708054

Identifier Type: -

Identifier Source: org_study_id

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