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Role of Thymus-And Activation-Regulated Chemokine (TARC) In Diagnosis Of Allergic Bronchopulmonary Aspergillosis

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ClinicalTrials.gov Identifier: NCT03267394
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hager sayed, Assiut University

Brief Summary:
This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.

Condition or disease
Thymus and Activation Regulated Chemokine

Detailed Description:

Allergic bronchopulmonary Aspergillosis (ABPA) is a pulmonary hypersensitivity disease mediated by an allergic response to Aspergillus fumigates. ABPA occurs in, 10% of cystic fibrosis (CF) patients and may lead to acute worsening of respiratory status and ongoing decline in lung function, ultimately progressing to a chronic state and lung fibrosis without adequate treatment. Despite the existence of the gold-standard Nelson criteria, diagnosis of ABPA in CF patients remains difficult. The wide variation in diagnostic practices between clinics, different estimates of prevalence and a delay in recognition lead to under treatment (Virnig and Bush 2007).

The main reason for the difficulties in diagnosis of ABPA and ABPA exacerbations in CF patients is the overlap of diagnostic criteria for ABPA with common manifestations of CF. Pulmonary infiltrates, obstructive lung disease and bronchiectasis occur regularly in CF patients, due to the underlying disease with bacterial colonisation, and thus are not specific to ABPA. Furthermore lung colonisation with A. fumigatus occurs in 20-25% of CF patients. Therefore, as stated in the most recent consensus document on diagnosis and therapy of ABPA in CF patients, serological findings should contribute strongly to the confirmation or exclusion of clinically suspected ABPA (Stevens, Moss et al. 2003).

The diagnosis of allergic bronchopulmonary Aspergillosis (ABPA) in cystic fibrosis (CF) is a challenge. Thymus- and activation-regulated chemokine (TARC) has recently been reported to play a role in ABPA (Latzin, Hartl et al. 2008).

TARC levels (analyzed by sandwich ELISA) increased early in the course of ABPA, before total IgE elevation, with an inverse correlation between TARC levels and spirometric parameters (FEV 1) identified in CF patient with ABPA. Elevated TARC level was strongly correlated with the level of rAsp f4 in ABPA patients, while no association was found with the other recombinants (rAsp f1, f2, f3 and f6). This biomarker showed a greater test accuracy for ABPA diagnosis than all other biological markers tested (total IgE, specific c IgG and antibodies against recombinants allergens rAsp f1, rAsp f3, rAsp f4 and rAsp f6). It seems to be able to differentiate CF patients with ABPA from those colonized or sensitized to A. fumigatus. Furthermore, corticotherapy decreases the TARC secretion, producing a rapid decrease of serum TARC level that can be used to follow patient evolution as well as the effect of corticosteroid therapy in ABPA (Delhaes, Frealle et al. 2010).


Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Thymus-And Activation-Regulated Chemokine (TARC) In Diagnosis Of Allergic Bronchopulmonary Aspergillosis
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis




Primary Outcome Measures :
  1. thymus and activation regulated chemokine (TARC) in diagnosis of Allergic bronchopulmonary aspergellosis [ Time Frame: base line ]
    This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The included patients will be subjected to:

  1. History and clinical examination.
  2. Spirometry and reversibility test.
  3. Radiological investigation:

    • Plain chest X-ray.
    • Chest HRCT chest.
  4. Laboratory investigations including:

    • Routine lab. Investigation: (CBC, liver function tests, renal function tests).
    • Serum eosinophilia.
    • Immunological investigations:

      • Total IGE.
      • New marker thymus-and activation-regulated chemokine (TARC).
Criteria

Inclusion Criteria:

  • • In this study patients referred from chest department for diagnosis of allergic pulmonary Aspergillosis will be included.

Exclusion Criteria:

  • • Pregnancy

    • Lactating women

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): NCT03267394


Contacts
Contact: hager Sayed, clinical pathology resident 01069199343 hs11492@yahoo.com
Contact: Mohammed Ismail 01020058069 moh_ismail310@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:
Responsible Party: Hager sayed, Egypt-Assiut, Assiut University
ClinicalTrials.gov Identifier: NCT03267394     History of Changes
Other Study ID Numbers: TARC in diagnosis of ABPA
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Aspergillosis, Allergic Bronchopulmonary
Aspergillosis
Pulmonary Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases