TerminatedNCT03172403MYOCACUpdated Aug 25, 2022

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

An interventional study of Height and weight and Blood samples in Cancer of Digestive System, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-25.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Basic science

Why this study was terminated

The study was stopped prematurely by decision of the sponsor due to lack of inclusion.

Phase: Not applicable
Study type: Interventional
Enrollment: 3
Allocation: Not applicable
Ages: 40 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Cancer of Digestive System

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Keywords

Cachexia
Cancer of Digestive System
Myostatin
Skeletal muscle

In context

Digestive System Neoplasms

315 studies on the registry are indexed under Digestive System Neoplasms; 83 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 235 interventional studies indexed under Digestive System Neoplasms.

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Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Browse Centre Hospitalier Universitaire de Saint Etienne studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 3 participants (actual)

Study arms

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 · Diagnostic Test: Blood samples · Diagnostic Test: Skeletal muscle force · Diagnostic Test: Skeletal muscle index · Diagnostic Test: Muscle biopsy

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)

What researchers measure

Primary outcomes

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.
Time frame: Day 1

Secondary outcomes

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.
Time frame: Baseline from 7 months
Correlation between level of myostatin muscular expression and degree myostatin
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 2

Study locations

1 site

CHU Saint-Etienne
Saint-Etienne, 42055, France

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2018 to primary completion in Jan 2019, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered: May 23, 2017
First posted: Jun 1, 2017
StartActual: Aug 2, 2018
Primary completionActual: Jan 3, 2019
CompletionActual: Aug 1, 2019
Last update: Aug 25, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03172403
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Responsible party: Sponsor
First posted: Jun 1, 2017
Start date: Aug 2, 2018
Primary completion: Jan 3, 2019
Completion: Aug 1, 2019
Last update: Aug 25, 2022

Study contacts

Karine ABBOUD, MD

principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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