Chronic Pulmonary AspergillosisNCT03027089
Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA)-Multicenter Study
An observational study of Chronic Pulmonary Aspergillosis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA) Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pulmonary Aspergillosis
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects were selected with lesions presented as cavity, nodule，mass or "destroyed lung" caused by fibrosis in CT imaging
Who may be able to join
- 18 years to 85 years Lesions presented as cavity, nodule，mass or "destroyed lung" caused by fibrosis in CT imaging
Who cannot join
- seriously immunocompromised patients
- Recent history of neutropenia (<0.5 × 109neutrophils/L [<500 neutrophils/mm3] for>10 days) temporally related to the onset of fungal disease
- Receipt of an allogeneic stem cell transplant
- Prolonged use of corticosteroids (excluding among patients with allergic bronchopulmonary aspergillosis) at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for >3 weeks
- Treatment with other recognized T cell immunosuppressants, such as cyclosporine, TNF-a blockers, specific monoclonal antibodies (such as alemtuzumab), or nucleoside analogues during the past 90 days
- Inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency)
Show all 10Show fewer
- antifungal drug use within 3 months of screening
- dropout
- Pregnancy or lactation
- no inform consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
301 PLA general hospital
Beijing, Beijing Municipality, 100853
xiuqing ma, Doctor, +8601066936184
About this study
Official title: Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA) in Chinese Patients -Multicenter Study
Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)
Read the detailed description
chronic pulmonary aspergillosis (CPA) is one of the most refractory pulmonary infectious diseases, and the incidence is increased rapidly in recent years. Serum detection of Aspergillus-specific IgG is considered to be the most reliable method for diagnosing CPA, however, there is no formal report on the appropriate cut-off value for Aspergillus-specific IgG assay in Chinese patients. This study aimed to establish the datum.
Besides aspergillus-specific IgG, there are two other specific antibodies IgM and IgA. IgM is associated with the acute phase of an infection and IgA is associated with mucosal immunity. Their diagnostic values in CPA are still not clear. Meanwhile, whether detection of antibody levels in bronchoalveolar lavage fluid (BALF) could be useful in diagnosis of CPA has not been investigated. In this study, the serum and BALF levels of IgG, IgM and IgA would be detected simultaneously by the commercial available kits.
The investigators will establish the cut-off values of three antibodies by proven CPA patients and negative controls. Then, the cut-off values will be assessed in participants who have a suspected CPA, and the sensitivity, specificity, positive and negative predict value of the antibodies assays will be compared with that of standard diagnostic methods.
After performing the above diagnostic tests, CPA could be diagnosed more accurately and rapidly, so that the antifungal therapy could be evaluated more correctly and timely.
- Conditions
- Chronic Pulmonary Aspergillosis
- Keywords
- Aspergillus-specific IgG
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of Aspergillus-specific IgG, IgM and IgA in sera and BALF from 560 patients with suspected CPA and 100 healthy blood donors were tested by ELISA assays
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Air Force General Hospital of the PLA, 307 Hospital of PLA
- Responsible party
- Principal investigator, Lixin Xie, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027089
- Sponsor's protocol ID
- hr4987
- Status last verified
- Jan 2017
- First submitted
- 14 Jan 2017
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Denning DW, Cadranel J, Beigelman-Aubry C, Ader F, Chakrabarti A, Blot S, Ullmann AJ, Dimopoulos G, Lange C; European Society for Clinical Microbiology and Infectious Diseases and European Respiratory Society. Chronic pulmonary aspergillosis: rationale and clinical guidelines for diagnosis and management. Eur Respir J. 2016 Jan;47(1):45-68. doi: 10.1183/13993003.00583-2015.
PubMed 26699723Page ID, Richardson MD, Denning DW. Comparison of six Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA). J Infect. 2016 Feb;72(2):240-9. doi: 10.1016/j.jinf.2015.11.003. Epub 2015 Dec 8.
PubMed 26680697Ma X, Wang K, Zhao X, Liu Y, Li Y, Yu X, Li C, Denning DW, Xie L. Prospective study of the serum Aspergillus-specific IgG, IgA and IgM assays for chronic pulmonary aspergillosis diagnosis. BMC Infect Dis. 2019 Aug 6;19(1):694. doi: 10.1186/s12879-019-4303-x.
PubMed 31387539
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA) in Chinese Patients -Multicenter Study
- ClinicalTrials.gov ID
- NCT03027089
- Acronym / sponsor ID
- hr4987
- Conditions
- Chronic Pulmonary Aspergillosis
- Keywords
- Aspergillus-specific IgG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Air Force General Hospital of the PLA, 307 Hospital of PLA
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- 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.
Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)
Detailed description
chronic pulmonary aspergillosis (CPA) is one of the most refractory pulmonary infectious diseases, and the incidence is increased rapidly in recent years. Serum detection of Aspergillus-specific IgG is considered to be the most reliable method for diagnosing CPA, however, there is no formal report on the appropriate cut-off value for Aspergillus-specific IgG assay in Chinese patients. This study aimed to establish the datum.
Besides aspergillus-specific IgG, there are two other specific antibodies IgM and IgA. IgM is associated with the acute phase of an infection and IgA is associated with mucosal immunity. Their diagnostic values in CPA are still not clear. Meanwhile, whether detection of antibody levels in bronchoalveolar lavage fluid (BALF) could be useful in diagnosis of CPA has not been investigated. In this study, the serum and BALF levels of IgG, IgM and IgA would be detected simultaneously by the commercial available kits.
The investigators will establish the cut-off values of three antibodies by proven CPA patients and negative controls. Then, the cut-off values will be assessed in participants who have a suspected CPA, and the sensitivity, specificity, positive and negative predict value of the antibodies assays will be compared with that of standard diagnostic methods.
After performing the above diagnostic tests, CPA could be diagnosed more accurately and rapidly, so that the antifungal therapy could be evaluated more correctly and timely.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects were selected with lesions presented as cavity, nodule，mass or "destroyed lung" caused by fibrosis in CT imaging
Key inclusion criteria (1 listed)
- 18 years to 85 years Lesions presented as cavity, nodule，mass or "destroyed lung" caused by fibrosis in CT imaging
Key exclusion criteria (10 listed)
- seriously immunocompromised patients
- antifungal drug use within 3 months of screening
- dropout
- Pregnancy or lactation
- no inform consent
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
The levels of Aspergillus-specific IgG, IgM and IgA in sera and BALF from 560 patients with suspected CPA and 100 healthy blood donors were tested by ELISA assays
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Results publication: PubMed 26699723Denning DW, Cadranel J, Beigelman-Aubry C, Ader F, Chakrabarti A, Blot S, Ullmann AJ, Dimopoulos G, Lange C; European Society for Clinical Microbiology and Infectious Diseases and European Respiratory Society. Chronic pulmonary aspergillosis: rationale and clinical guidelines for diagnosis and management. Eur Respir J. 2016 Jan;47(1):45-68. doi: 10.1183/13993003.00583-2015.
- Results publication: PubMed 26680697Page ID, Richardson MD, Denning DW. Comparison of six Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA). J Infect. 2016 Feb;72(2):240-9. doi: 10.1016/j.jinf.2015.11.003. Epub 2015 Dec 8.
- Derived from this study: PubMed 31387539Ma X, Wang K, Zhao X, Liu Y, Li Y, Yu X, Li C, Denning DW, Xie L. Prospective study of the serum Aspergillus-specific IgG, IgA and IgM assays for chronic pulmonary aspergillosis diagnosis. BMC Infect Dis. 2019 Aug 6;19(1):694. doi: 10.1186/s12879-019-4303-x.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pulmonary Aspergillosis, run by Chinese PLA General Hospital at 1 site in China.
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 10 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 xiuqing ma, Doctor (+8601066936184, mxq820812@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The levels of Aspergillus-specific IgG, IgM and IgA in sera and BALF from 560 patients with suspected CPA and 100 healthy blood donors were tested by ELISA assays (time frame: 2 years). 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 NCT03027089, which also lists 3 linked publications.
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 20 Jan 2017.