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Trial record 11 of 244105 for:    Diseases

Novel Biomarkers in Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03833310
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nesma Gamal, Assiut University

Brief Summary:

The inflammatory bowel diseases represent a heterogeneous group of chronic , relapsing- inflammatory disorders of the gastrointestinal tract. Crohn's disease and ulcerative colitis are the two major clinical forms.The global incidence and prevalence of the inflammatory bowel diseases has increased over the last 2-4 decades . Despite the great progress in understanding the pathogenesis of these diseases, their etiology remains unclear . Considerable effort has been devoted to the development of an accurate ,noninvasive biomarkers that have increased diagnostic sensitivity and specificity .

Osteoprotegerin is a member of the Tumor Necrosis Factor Receptor superfamily of proteins. Osteoprotegerin is of particular importance in bone metabolism, inflammation , tumorigenesis, and other processes where cell differentiation, survival, and death are controlled. Osteoprotegerin activates inflammation in the gut by stimulating immune cells, cytokines, and the Necrosis factor-κappaB pathway .

Soluble Receptor activator of nuclear factor kappa-Β ligand is known as a type II membrane protein and as a member of tumor necrosis factor superfamily . Soluble Receptor activator of nuclear factor kappa-Β ligand has been identified to affect the immune system and a binding partner of ( Osteoprotegerin ), and controls cell proliferation.The interactions between Osteoprotegerin and Soluble Receptor activator of nuclear factor kappa-Β ligand, Soluble Receptor activator of nuclear factor kappa-Β have relevance to inflammatory pathways. Soluble Receptor activator of nuclear factor kappa-Β ligand- Soluble Receptor activator of nuclear factor kappa-Β ligand binding activates pathways that contribute to the survival of T-lymphocytes and dendritic cells .


Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Diagnostic Test: Osteoprotegerin marker in serum in inflammatory bowel disease

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Novel Biomarkers in Diagnosis of Inflammatory Bowel Disease
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : December 30, 2022

Intervention Details:
  • Diagnostic Test: Osteoprotegerin marker in serum in inflammatory bowel disease
    I will measure Osteoprotegerin and Soluble Receptor activator of nuclear factor kappa-Β ligand markers in serum of patient with inflammatory bowel disease


Primary Outcome Measures :
  1. level of Osteoprotegerin and sRANKL in newly diagnosed patients with inflammatory bowel disease [ Time Frame: 2 years ]
    measuring level of Osteoprotegerin and sRANKL in newly diagnosed patients with inflammatory bowel disease then it will measured again after treated with infliximab


Biospecimen Retention:   Samples With DNA
serum specimen from patient with inflammatory bowel disease after diagnosis and healthy persons .second sample taking 3month after received treatment


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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
After standardized work-up with clinical, endoscopic, histopathologicial and, when applicable, radiological evaluation, all patients will met the generally accepted international diagnostic criteria of inflamatory bowel diseaes .The healthy controls consisted of an age- and gender-matched (negative for IBD). This group did not show evidence or familial history of IBD or any other immune mediated disorders
Criteria

Inclusion Criteria:

  • Newly diagnosed patients (untreated) by clinical and endoscopic examination and not received treatment .

Exclusion Criteria:

  • patients have autoimmune diseases
  • patients with cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833310


Contacts
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Contact: ragaa salama, professor 01063492008 ragaa_2002@yahoo.com
Contact: Amira Abdel Hamid Kamal Mohamed 01068345861 Amira_Kamel222@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: nesma gamal, demonstrator Assiut University

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Responsible Party: Nesma Gamal, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03833310     History of Changes
Other Study ID Numbers: vosrd
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis