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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04266587
Other study ID # 2019/0350/HP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2020
Est. completion date November 2020

Study information

Verified date June 2020
Source University Hospital, Rouen
Contact Francois FRAISSINET
Phone +3323288
Email francois.fraissinet@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ACTH is a peptide secreted by pituitary gland and plays an important role in regulating cortisol secretion. ACTH is determined in plasma by immunoassays using specific antibodies. Its determination is difficult because of instability in whole blood. Several factors which influence ACTH stability in blood before analysis have been identified: temperature, hemolysis, time to centrifugation and presence of protease inhibitors. Published results on ACTH whole blood stability seem contradictory.

The objective of this study is to evaluate the effect of aprotinin in 10 healthy volunteers. ACTH measurements will be performed on cobas e602 (Roche Diagnostics, Mannheim, Germany).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adult patient aged 18 to 60,

Exclusion Criteria:

- Adult with insufficient venous capital for blood collection

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood sampling
blood sampling is done on healthy volunteers

Locations

Country Name City State
France Rouen University Hospital Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary ACTH concentration in plasma 8 hours
See also
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Active, not recruiting NCT05279118 - Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome Phase 2/Phase 3
Completed NCT01294319 - Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men Phase 2
Recruiting NCT02019706 - Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome Phase 2