NCT03172403

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

May 23, 2017

Last Update Submit

August 22, 2022

Conditions

Cancer of Digestive System

Keywords

CachexiaCancer of Digestive SystemMyostatinSkeletal muscle

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (6)

  • Correlation between skeletal muscle force and index before resection surgery

    Baseline from 7 months

  • Correlation between level of myostatin muscular expression and degree myostatin

    Month 2

  • Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery

    Month 2

  • Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery

    Month 4

  • Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery

    Month 7

  • +1 more secondary outcomes

Study Arms (1)

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

Diagnostic Test: Height and weightDiagnostic Test: Blood samplesDiagnostic Test: Skeletal muscle forceDiagnostic Test: Skeletal muscle indexDiagnostic Test: Muscle biopsy

Interventions

Height and weightDIAGNOSTIC_TEST

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

Patients with digestive cancer requiring resection surgery
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)

Patients with digestive cancer requiring resection surgery
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)

Patients with digestive cancer requiring resection surgery
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)

Patients with digestive cancer requiring resection surgery
Muscle biopsyDIAGNOSTIC_TEST

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

Patients with digestive cancer requiring resection surgery

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Digestive System NeoplasmsCachexia

Interventions

Body HeightBlood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Intervention Hierarchy (Ancestors)

Body SizeBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Appearance, BodyAnthropometryInvestigative TechniquesPhysiological PhenomenaGrowthGrowth and DevelopmentSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, Operative

Study Officials

  • Karine ABBOUD, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 1, 2017

Study Start

August 2, 2018

Primary Completion

January 3, 2019

Study Completion

August 1, 2019

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)