ACTHSTABACTNCT04266587
ACTH Stability on Whole Blood
A study testing Blood sampling in people with ACTH, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- ACTH
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2021to 18 Nov 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient aged 18 to 60,
Who cannot join
- Adult with insufficient venous capital for blood collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adrenocorticotropic Hormone Stability on Whole Blood
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).
- Conditions
- ACTH
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
blood sampling is done on healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | blood sampling is done on healthy volunteers Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACTH concentration in plasma
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start18 Nov 2021
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACTHStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois FRAISSINET, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266587
- Sponsor's protocol ID
- 2019/0350/HP
- Acronym
- STABACT
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2020
- Last updated
- 10 Feb 2026
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenocorticotropic Hormone Stability on Whole Blood
- ClinicalTrials.gov ID
- NCT04266587
- Acronym / sponsor ID
- STABACT / 2019/0350/HP
- Conditions
- ACTH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 12 Feb 2020 (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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Biological: Blood samplingblood sampling is done on healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient aged 18 to 60,
Key exclusion criteria (1 listed)
- Adult with insufficient venous capital for blood collection
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 |
|---|---|---|
| Blood samplingblood sampling is done on healthy volunteers | Biological | Healthy volunteers |
Primary outcome
ACTH concentration in plasma
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Francois FRAISSINET principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with ACTH, run by University Hospital, Rouen 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ACTH concentration in plasma (time frame: 8 hours). 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 10 Feb 2026.