Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis

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Brief Title

Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis

Official Title

Cohort Study of Chinese Patients With Pulmonary Vasculitis

Brief Summary

      The purpose of this study is to observe the clinical manifestation, Lab findings including
      chest CT scans, pathological findings and outcomes in chinese patients with pulminary
      vasculitis.
    

Detailed Description

      Presentation of patient with suspected vasculitis

        1. Established diagnosis Clinical findings Laboratory workup Tissue biopsy Angiogram where
           appropriate

        2. Evaluating respiratory system Chest HRCT Pulmonary function test Bronchoscopy exam(BALF,
           TBB) Lung biopsy(needle biopsy, VAST)

        3. screening underlying damage to other system Paranasal sinus, vision & audition Nervous
           system Kidney Gastrointestinal tract Heart & vessel Skin Hematology Muscle, bone & joint

        4. Treatment

        5. Prognosis

      Evaluation

        1. Study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months.

        2. Disease activity was measured on the basis of the BVAS/WG and the physician's global
           assessment.

        3. Damage related to disease or treatment was scored according to the Vasculitis Damage
           Index (scores for this index range from 0 to 64, with higher scores in- dicating more
           severe damage).

        4. Health related quality of life was scored with the use of the Med- ical Outcomes Study
           36-Item Short-Form Health Survey (SF-36).Scores on this scale range from 0 to 100, with
           higher scores indicating better health.

        5. Serial serum samples were tested for proteinase 3-ANCA and myeloperoxidase-ANCA by means
           of a direct enzyme-linked immunosorbent assay (ELISA).
    


Study Type

Observational [Patient Registry]


Primary Outcome

Completely Remission

Secondary Outcome

 Disease flare

Condition

ANCA-associated Vasculitis


Study Arms / Comparison Groups

 Adults who diagosed ANCA-vasculitis
Description:  Patients with Wegener's granulomatosis or microscopic polyangiitis were eligible to participate in the study if they had
Positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA
manifestations of severe disease,11 and a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

May 2014

Completion Date

December 2017

Primary Completion Date

November 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Males and Females

          -  Aged from 18-75 years with informed consent

          -  Patients with ANCA-vasculitis

               1. Wegener's granulomatosis, microscopic polyangiitis or CSS

               2. positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA

               3. manifestations of activity disease, and Birmingham Vasculitis Activity Score for
                  Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with
                  higher scores indicating more active disease)

        Exclusion Criteria:

          -  Females planning to bear a child recently or with childbearing potential

          -  Secondary vasculitis, cancer,infective disease or drug induced vasculitis
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Juhong Shi, M.D, +861069155028, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02126098

Organization ID

PUMCH-PULMONARY DISEASES

Secondary IDs

2011BA11B17

Responsible Party

Sponsor

Study Sponsor

Peking Union Medical College Hospital


Study Sponsor

Juhong Shi, M.D, Study Chair, Peking Union Medical College Hospital


Verification Date

April 2014