Thymus and Activation Regulated ChemokineNCT03267394
Role of Thymus-And Activation-Regulated Chemokine (TARC) In Diagnosis Of Allergic Bronchopulmonary Aspergillosis
An observational study of Thymus and Activation Regulated Chemokine, run by Assiut University.
Trial summary
This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thymus and Activation Regulated Chemokine
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- • In this study patients referred from chest department for diagnosis of allergic pulmonary Aspergillosis will be included.
Who cannot join
- • Pregnancy
- Lactating women
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.
Read the 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
thymus and activation regulated chemokine (TARC) in diagnosis of Allergic bronchopulmonary aspergellosis
This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study startOct 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thymus and Activation Regulated ChemokineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267394
- Sponsor's protocol ID
- TARC in diagnosis of ABPA
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17133128
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Thymus-And Activation-Regulated Chemokine (TARC) In Diagnosis Of Allergic Bronchopulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT03267394
- Acronym / sponsor ID
- TARC in diagnosis of ABPA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- • In this study patients referred from chest department for diagnosis of allergic pulmonary Aspergillosis will be included.
Key exclusion criteria (2 listed)
- • Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Background: PubMed 17133128Virnig C, Bush RK. Allergic bronchopulmonary aspergillosis: a US perspective. Curr Opin Pulm Med. 2007 Jan;13(1):67-71. doi: 10.1097/MCP.0b013e328010c812.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Thymus and Activation Regulated Chemokine, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hager Sayed, clinical pathology resident (01069199343, hs11492@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thymus and activation regulated chemokine (TARC) in diagnosis of Allergic bronchopulmonary aspergellosis (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.