Cancer of Digestive SystemMYOCACNCT03172403
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia
A study testing Height and weight, Blood samples and Skeletal muscle force in people with Cancer of Digestive System, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cancer of Digestive System
- What is being tested?
- Height and weight, Blood samples and Skeletal muscle force
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)
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
- Cancer of Digestive System
- Being tested
- Height and weight, Blood samples, Skeletal muscle force, Skeletal muscle index, Muscle biopsy
- Keywords
- Cachexia, Cancer of Digestive System, Myostatin, Skeletal muscle
- Medical subject headings
- Digestive System Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Height and weightDiagnostic test
Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1)
Blood samplesDiagnostic 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 forceDiagnostic 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 indexDiagnostic 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 biopsyDiagnostic test
Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)
| Study group | Role | What they receive |
|---|---|---|
| Patients with digestive cancer requiring resection surgery | Experimental | 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 Receives: Diagnostic Test: Height and weight; Diagnostic Test: Blood samples; Diagnostic Test: Skeletal muscle force; Diagnostic Test: Skeletal muscle index; Diagnostic Test: Muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start2 Aug 2018
- Primary completion3 Jan 2019
- Study completion1 Aug 2019
Why it stopped: The study was stopped prematurely by decision of the sponsor due to lack of inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Digestive SystemStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine ABBOUD, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172403
- Sponsor's protocol ID
- 1708054
- Other IDs
- ANSM
- Acronym
- MYOCAC
- Status last verified
- Aug 2022
- First submitted
- 23 May 2017
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)
- ClinicalTrials.gov ID
- NCT03172403
- Acronym / sponsor ID
- MYOCAC / 1708054
- Conditions
- Cancer of Digestive System
- Keywords
- Cachexia, Cancer of Digestive System, Myostatin, Skeletal muscle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely by decision of the sponsor due to lack of inclusion.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with digestive cancer requiring resection surgery | Experimental | Diagnostic Test: Height and weight, Diagnostic Test: Blood samples, Diagnostic Test: Skeletal muscle force, Diagnostic Test: Skeletal muscle index, Diagnostic Test: Muscle biopsyPatients 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Height and weightHeight and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1) | Diagnostic test | Patients with digestive cancer requiring resection surgery |
| Blood samplesBlood 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 | Patients with digestive cancer requiring resection surgery |
| Skeletal muscle forceSkeletal 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 | Patients with digestive cancer requiring resection surgery |
| Skeletal muscle indexSkeletal 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 | Patients with digestive cancer requiring resection surgery |
| Muscle biopsyMuscle biopsy will be performed during resection surgery under general anaesthesia. (V2) | Diagnostic test | Patients with digestive cancer requiring resection surgery |
Primary outcome
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.
6 secondary outcomes
Correlation between skeletal muscle force and index before resection surgery
Time frame: Baseline from 7 months
Correlation between level of myostatin muscular expression and degree myostatin
Time frame: Month 2
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
Time frame: Month 4
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
Time frame: Month 2
Results and safety
The study was stopped early (reason given: The study was stopped prematurely by decision of the sponsor due to lack of inclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Cancer of Digestive System
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine ABBOUD, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Height and weight, Blood samples and Skeletal muscle force in people with Cancer of Digestive System, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped prematurely by decision of the sponsor due to lack of inclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between skeletal muscle and degree myostatin (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.