Healthy Clinical Trial - Evaluation of the Diagnostic Value of microRNAs

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

Clinical Trial Description

RATIONAL Inflammatory Bowel Disease (IBD) affects more than 200,000 people in France and 1.5 million in Europe. Difficulties in the management of IBD are related to the need for invasive tests for the diagnosis of IBD (endoscopy), partly explaining the delay in diagnosis, and the inability to distinguish early colonic Crohn's disease of ulcerative colitis (UC) in 10-30% of cases.

Recently, we identified real-time polymerase chain reaction (PCR), from healthy colonic mucosa of IBD patients, a molecular signature of IBD involving 10 microRNA (miRNA) Common (miR26a, miR29a, miR29b, miR126 * miR15a, miR127-3p, miR324 -3p, miR30c, miR185, miR196a) and 15 colic chronic disease (MC) and ulcerative colitis (RCH) discriminating microRNA (miR-142-3p, miR-142-5p, miR-146a, miR-146b-5p, miR150, miR-181d, miR-182, miR199a -3p, miR199a-5p, miR199b-5p, miR-203, miR223, miR-299-5p, miR320a, miR-328).

TYPE OF STUDY : multicenter diagnostic evaluation Study

MAIN PURPOSE OF THE STUDY : To evaluate the diagnostic value of microRNA in colonic IBD (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

SECONDARY OBJECTIVES :

- assess the ability of microRNA to discriminate a colic chronic disease (MC) of ulcerative colitis (RCH) in adults

- evaluate the diagnostic value of microRNA in inflammatory colitis child

- explore the possibility of measuring miRNA of interest in the stool

PRODUCTS OF THE STUDY diagnostic kit of IBD in quantitative polymerase chain reaction (qPCR)

NUMBER OF PATIENTS : 6 groups of 50 patients each will be included

- Group 1: Crohn adult colic

- Group 2: ulcerative colitis (RCH) adults

- Group 3: Witnesses healthy adults

- Group 4: Witnesses adults with non-IBD inflammation

- Group 5: Children with colitis

- Group 6 : Witnesses healthy children

INCLUSION LENGTH 30 months

DURATION OF THE STUDY 30 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02020382
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	December 2013
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06052553` - A Study of TopSpin360 Training Device	N/A
Completed	`NCT05511077` - Biomarkers of Oat Product Intake: The BiOAT Marker Study	N/A
Recruiting	`NCT04632485` - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed	`NCT05931237` - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults	N/A
Completed	`NCT04527718` - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers	Phase 1
Terminated	`NCT04556032` - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women	N/A
Completed	`NCT04998695` - Health Effects of Consuming Olive Pomace Oil	N/A
Completed	`NCT04107441` - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects	Phase 1
Completed	`NCT04065295` - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225	Phase 1
Completed	`NCT01442831` - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects	Phase 1
Terminated	`NCT05934942` - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood	Phase 1
Recruiting	`NCT05525845` - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI	N/A
Completed	`NCT05515328` - A Study in Healthy Men to Test How BI 685509 is Processed in the Body	Phase 1
Completed	`NCT04967157` - Cognitive Effects of Citicoline on Attention in Healthy Men and Women	N/A
Completed	`NCT05030857` - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects	Phase 1
Recruiting	`NCT04714294` - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers	Phase 1
Recruiting	`NCT04494269` - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls	Phase 1
Completed	`NCT04539756` - Writing Activities and Emotions	N/A
Recruiting	`NCT04098510` - Concentration of MitoQ in Human Skeletal Muscle	N/A
Completed	`NCT03308110` - Bioavailability and Food Effect Study of Two Formulations of PF-06650833	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases — MicroMICI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms