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

NCT ID: NCT03267394

Last Updated: 2017-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thymus and Activation Regulated Chemokine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* • Pregnancy

* Lactating women
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hager sayed

Egypt-Assiut

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

hager Sayed, clinical pathology resident

Role: CONTACT

01069199343

Mohammed Ismail

Role: CONTACT

01020058069

References

Explore related publications, articles, or registry entries linked to this study.

Virnig C, Bush RK. Allergic bronchopulmonary aspergillosis: a US perspective. Curr Opin Pulm Med. 2007 Jan;13(1):67-71. doi: 10.1097/MCP.0b013e328010c812.

Reference Type BACKGROUND
PMID: 17133128 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TARC in diagnosis of ABPA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tumor-specific T Cells in Lung Cancer
NCT02515760 ACTIVE_NOT_RECRUITING NA
Thymosin Alpha-1 for irAE Secondary to ICIs
NCT06178146 RECRUITING PHASE4
Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma
NCT00863395 TERMINATED PHASE1/PHASE2