Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers
MYOCACH
2 other identifiers
observational
60
1 country
1
Brief Summary
The main objective of our study was to determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers. Secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2015
1 active site
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
Study Start
First participant enrolled
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedMay 22, 2017
May 1, 2017
3 months
May 5, 2017
May 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Measure of plasma activin A (pg/ml)
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
at day 1
Measure of plasma follistation (pg/ml)
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
at day 1
Measure of plasma myostatin (pg/ml)
determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers
at day 1
Secondary Outcomes (1)
Influence on the occurrence of cachexia
at day 1
Study Arms (2)
Squamous cell carcinoma
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
Control group
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
Interventions
Eligibility Criteria
55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group.
You may qualify if:
- For case group :
- head and neck cancer
- squamous cell carinoma only
- head and neck surgery chosen as treatment of cancer
- age 18-75
- For control group :
- Neck surgery for non oncologic disease
- age 18-75
You may not qualify if:
- heart failure, respiratory failure (requiring a long-term oxygen therapy), chronic renal failure (MDRD clearance \< 60 ml/min), moderate or severe chronic obstructive pulmonary disease and insulin-dependent diabeta for the two groups
- cachexia for control group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 22, 2017
Study Start
November 2, 2015
Primary Completion
February 1, 2016
Study Completion
May 1, 2017
Last Updated
May 22, 2017
Record last verified: 2017-05