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Trial registered on ANZCTR


Registration number
ACTRN12610000425099
Ethics application status
Approved
Date submitted
24/05/2010
Date registered
26/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the reliability of blood Cortisol concentration essay using Electro-ChemiLuminescence ImmunoAssay compared to liquid chromatography-tandem-mass spectrometry in patients with ulcerative colitis treated with oral Prednisone
Scientific title
Evaluation of the reliability of blood Cortisol concentration essay using Electro-ChemiLuminescence ImmunoAssay (ECLIA) compared to liquid chromatography-tandem-mass spectrometry (LC/MS/MS) in patients with ulcerative colitis (UC) treated with oral Prednisone: ELICA Study
Secondary ID [1] 251839 0
U1111-1115-1048
Universal Trial Number (UTN)
Trial acronym
ELICA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To compare circulating concentrations of Cortisol measured using two different laboratory methods: the ECLIA COBAS assay and the high-specificity LC/MS/MS assay in patients affected by ulcerative colitis, in treatment with oral Prednisone. 257439 0
Condition category
Condition code
Oral and Gastrointestinal 257588 257588 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Glucocorticosteroids are, together with aminosalicylates, drugs of choice for the management of ulcerative colitis (UC). Patients undergoing repeated oral administrations of Hydrocortisone or Prednisone may experience a variety of adverse effects, some of which of concerning clinical relevance. With regards to Cortisol plasma levels, a specific safety endpoint in the various clinical trials concerning the use of glucocorticosteroids in UC is represented by the morning Cortisol levels below the lower limit of the normal range during treatment. Prednisolone and its metabolites are known to be chemically similar to serum Cortisol and might therefore interfere with Cortisol measurements by radioimmunoassay (RIA). Analytical methods involving chromatographic separation of Cortisol from Prednisolone and its metabolites, such as high performance liquid chromatography (HPLC), circumvent this problem of interference. This study was planned to compare serum Cortisol measurements by both conventional RIA Electro-ChemiLuminescence ImmunoAssay (ECLIA) (Cobas) and by liquid chromatography with tandem mass spectrometric detection (LC/MS-MS) in patients with acute relapse of UC treated with oral Prednisone at a stable daily dose >= 30 mg in the last two weeks.
Intervention code [1] 256538 0
Not applicable
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258507 0
The primary aim of the study is to compare circulating concentrations of Cortisol measured using two different laboratory methods: the ECLIA COBAS assay and the high-specificity LC/MS/MS assay
Timepoint [1] 258507 0
Concentration measures will be collected once only upon recruitment into study
Secondary outcome [1] 264308 0
Nil
Timepoint [1] 264308 0
Nil

Eligibility
Key inclusion criteria
Both genders, age between 18 and 70 years (both included);
Clinical diagnosis of acute relapse of UC with extension of the disease above the rectum and indication for systemic corticosteroid (CS) treatment;
Continuous treatment with oral Prednisone at a daily dose >= 30 mg for at least the two weeks preceding enrollment
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ongoing local (enema) or systemic treatment with CS other than Prednisone;
Low compliance to medical treatment;
Presence of other diseases or treatments that are known to interfere with the evaluation of blood Cortisol concentrations as a measure of hypothalamic-pituitary-adrenal axis suppression

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2650 0
Italy
State/province [1] 2650 0

Funding & Sponsors
Funding source category [1] 257028 0
Hospital
Name [1] 257028 0
AORN A. Cardarelli
Country [1] 257028 0
Italy
Primary sponsor type
Individual
Name
Dr. Antonio Balzano
Address
AORN A. Cardarelli, UOC di Gastroenterologia, Via A. Cardarelli 9, 80131 Napoli
Country
Italy
Secondary sponsor category [1] 256284 0
Individual
Name [1] 256284 0
Dr. Francesco Manguso
Address [1] 256284 0
AORN A. Cardarelli, UOC di Gastroenterologia, Via A. Cardarelli 9, 80131 Napoli
Country [1] 256284 0
Italy
Other collaborator category [1] 1293 0
Individual
Name [1] 1293 0
Dr. Raffaele Bennato
Address [1] 1293 0
AORN A. Cardarelli, UOC di Gastroenterologia, Via A. Cardarelli 9, 80131 Napoli
Country [1] 1293 0
Italy
Other collaborator category [2] 1294 0
Individual
Name [2] 1294 0
Dr. Giovanni Lombardi
Address [2] 1294 0
AORN A. Cardarelli, UOC di Gastroenterologia, Via A. Cardarelli 9, 80131 Napoli
Country [2] 1294 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259043 0
Comitato Etico AORN "A. Cardarelli"
Ethics committee address [1] 259043 0
Via A. Cardarelli 9, 80131 Napoli
e-mail: [email protected]
Ethics committee country [1] 259043 0
Italy
Date submitted for ethics approval [1] 259043 0
Approval date [1] 259043 0
26/02/2010
Ethics approval number [1] 259043 0

Summary
Brief summary
Corticosteroids (CS), together with aminosalicylates, are drugs of choice for the management of ulcerative colitis (UC). Patients undergoing repeated oral administrations of Hydrocortisone or Prednisone may experience a variety of adverse effects, some of which of concerning clinical relevance. With regards to Cortisol plasma levels, a specific safety endpoint in the various clinical trials concerning the use of CS in UC is represented by the morning Cortisol levels below the lower limit of the normal range during treatment. Prednisolone and its metabolites are known to be chemically similar to serum cortisol and might therefore interfere with Cortisol measurements by radioimmunoassay (RIA). Analytical methods involving chromatographic separation of Cortisol from Prednisolone and its metabolites, such as high performance liquid chromatography (HPLC), circumvent this problem of interference. This study was planned to compare serum Cortisol measurements by both conventional RIA Electro-ChemiLuminescence ImmunoAssay (ECLIA) (Cobas) and by liquid chromatography with tandem mass spectrometric detection (LC/MS-MS) in patients with acute relapse of UC treated with oral Prednisone at a stable daily dose >= 30 mg in the last two weeks. A total of 20 in-patients and out-patients followed by the Gastroenterology Unit of the Cardarelli Hospital in Naples, Italy (UOC di Gastroenterologia ed Endoscopia Digestiva, Azienda Ospedaliera A. Cardarelli, Napoli) are required to complete this study. The inclusion criteria include: both genders, age between 18 and 70 years (both included); clinical diagnosis of acute relapse of UC with extension of the disease above the rectum and indication for systemic CS treatment; and continuous treatment with oral Prednisone at a daily dose >= 30 mg for at least the two weeks preceding enrollment. Exclusion criteria include: ongoing local (enema) or systemic treatment with CS other than Prednisone; low compliance to medical treatment; presence of other diseases or treatments that are known to interfere with the evaluation of blood Cortisol concentrations as a measure of hypothalamic-pituitary-adrenal axis suppression.
The study includes: 1) a “screening visit” for study presentation, informed consent signature, clinical data collection and inclusion/ exclusion criteria check; 2) a “blood drawn visit” to collect fasting blood specimen for Cortisol essay. In particular, screening visit includes the following activities: patient information and signature of the informed consent; demographic data collection and patient ID assignment; medical history and concomitant treatment data collection; physical examination and vital signs; verification of inclusion and exclusion criteria. If patients verify all the inclusion and none of the exclusion criteria, an appointment for the blood drawn visit is given.
Blood drawn visit includes the following activities: AEs and concomitant treatments collection;
inclusion/exclusion criteria re-check; vital signs; blood drawn in fasting conditions, at a 24 hour distance from last Prednisone dose, between 8AM and 9AM, of about 10-12 mL (about 8 mL in serum vials and about 2-4 mL in EDTA-coated vials). Blood specimens will be fresh centrifuged at about 2500 rpm for 15 minutes at +4 degrees C. After centrifugation, specimens will be divided into 4 aliquots:
-one aliquot of about 200 uL of plasma (from EDTA-treated blood) to determine circulating Cortisol by LC/MS/MS assay;
-one aliquot of about 1,5 mL of serum (from untreated blood) to determine circulating Cortisol by RIA ECLIA (Cobas) assay;
-one aliquot of about 200 uL of plasma to be stored at -20 degrees C as backup for possible re-analysis;
-one aliquot of about 1.5 mL of plasma to be stored at -20 degrees C as backup for possible re-analysis.
Specimens will be stored at -20 degrees C at the investigator site (laboratory of the Gastroenterology Unit) until shipment to the laboratory for Cortisol assay.
Primary evaluation parameter will be the difference between Cortisol concentrations assayed with the two methods. Data will be presented descriptively as mean, median, SD and 95% CI for the mean. As exploratory analysis, cortisol concentrations obtained with the two methods will be compared using paired t-test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31209 0
Address 31209 0
Country 31209 0
Phone 31209 0
Fax 31209 0
Email 31209 0
Contact person for public queries
Name 14456 0
Dr. Francesco Manguso
Address 14456 0
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country 14456 0
Italy
Phone 14456 0
+39 081 747 4034
Fax 14456 0
+39 081 747 3018
Email 14456 0
[email protected]
Contact person for scientific queries
Name 5384 0
Dr. Francesco Manguso
Address 5384 0
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country 5384 0
Italy
Phone 5384 0
+39 081 747 4034
Fax 5384 0
+39 081 747 3018
Email 5384 0
[email protected]

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