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Status unknownNCT03027089Updated Jan 20, 2017

Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA)-Multicenter Study

An observational study in Chronic Pulmonary Aspergillosis, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-20.

Sponsored by Chinese PLA General Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
560
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Pulmonary Aspergillosis

Keywords

  • Aspergillus-specific IgG
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In context

Aspergillosis

201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.

This study's planned enrollment of 560 is above the median of 150 across 81 observational studies indexed under Aspergillosis.

Browse Aspergillosis studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All subjects were selected with lesions presented as cavity, nodule，mass or "destroyed lung" caused by fibrosis in CT imaging

Inclusion criteria

18 years to 85 years Lesions presented as cavity, nodule，mass or "destroyed lung" caused by fibrosis in CT imaging

Exclusion criteria

Exclusion Criteria:

  • seriously immunocompromised patients

    1. Recent history of neutropenia (\<0.5 × 109neutrophils/L [\<500 neutrophils/mm3] for>10 days) temporally related to the onset of fungal disease
    2. Receipt of an allogeneic stem cell transplant
    3. 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
    4. 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
    5. Inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency)
  • antifungal drug use within 3 months of screening
  • dropout
  • Pregnancy or lactation
  • no inform consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
560 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • 301 PLA general hospital
    BeiJing, Beijing 100853, China
    • xiuqing ma, Doctor · Contact · +8601066936184
    Recruiting
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References and documents

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 26699723 ↗
  • Page 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 26680697 ↗
  • Ma 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03027089
Lead sponsor
Chinese PLA General Hospital
Collaborators
Navy General Hospital, Beijing, Air Force General Hospital of the PLA, 307 Hospital of PLA
Responsible party
Lixin Xie (professor, Chinese PLA General Hospital) — Principal investigator
First posted
Jan 20, 2017
Start date
Jan 2017
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jan 20, 2017

Study contacts

xiuqing ma, Doctor
Contact
mxq820812@163.com
+8601066936184

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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