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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]

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.

Condition category

Condition code

Oral and Gastrointestinal

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]

Not applicable

Comparator / control treatment

There is no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Concentration measures will be collected once only upon recruitment into study

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

AORN A. Cardarelli

Address [1]

Via A. Cardarelli 8, 80131 Napoli

Country [1]

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]

Individual

Name [1]

Dr. Francesco Manguso

Address [1]

AORN A. Cardarelli, UOC di Gastroenterologia, Via A. Cardarelli 9, 80131 Napoli

Country [1]

Italy

Other collaborator category [1]

Individual

Name [1]

Dr. Raffaele Bennato

Address [1]

AORN A. Cardarelli, UOC di Gastroenterologia, Via A. Cardarelli 9, 80131 Napoli

Country [1]

Italy

Other collaborator category [2]

Individual

Name [2]

Dr. Giovanni Lombardi

Address [2]

AORN A. Cardarelli, UOC di Gastroenterologia, Via A. Cardarelli 9, 80131 Napoli

Country [2]

Italy

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comitato Etico AORN "A. Cardarelli"

Ethics committee address [1]

Via A. Cardarelli 9, 80131 Napoli
e-mail: comitato.etico@ospedalecardarelli.it

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

Approval date [1]

26/02/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Francesco Manguso

Address

AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli

Country

Italy

Phone

+39 081 747 4034

Fax

+39 081 747 3018

[email protected]

Contact person for scientific queries

Name

Dr. Francesco Manguso

Address

AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli

Country

Italy

Phone

+39 081 747 4034

Fax

+39 081 747 3018

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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