Status:
UNKNOWN
Observational Study Evaluating the Prevalence of Enzyme Deficiency in Pulmonology Clinics (ADA)
Lead Sponsor:
TRPHARM
Conditions:
Bronchiectasis
Adenosine Deaminase Deficiency
Eligibility:
All Genders
18-40 years
Brief Summary
This observational study was designed as a prospective epidemiological screening study. Patients who applied to the centers participating in the study, bronchiectasis was detected on at least one comp...
Detailed Description
Bronchiectasis is a chronic disease characterized by abnormal and persistent expansion of the bronchi. Although its frequency is not clearly known in our country, it is considered to be 53-566/100,000...
Eligibility Criteria
Inclusion
- Signing of the written informed consent form by the patient and/or his legal representative,
- Detection of bronchiectasis (cystic fibrosis, non-primary ciliary dyskinesia) on at least one computed tomography of the patient's lungs,
- The patient is between dec8 and 40 years of age.
- Patients with at least one major and one minor criteria from the following criteria will be included in the study:
- Major Criteria:
- Lymphopenia: lymphopenia as a result of at least one hemogram of the patient exist,
- The number of lymphocytes is below 1500/mm3
- Immunoglobulin E height: 120 kU/L of immunoglobulin E level having it on
- Minor Criteria:
- Two or more new ear infections within a year
- Two or more new sinus infections within a year when there is no allergy
- One pneumonia per year for more than a year
- Chronic diarrhea with weight loss
- Recurrent viral infections (Colds, herpes, warts, condyloma)
- The need for repeated intravenous antibiotics to clear infections
- Recurrent deep skin or internal organ abscesses
- Persistent thrush or fungal infection of the skin or other place
- Infection caused by tuberculosis-like bacteria that is normally harmless
- Primary immunodeficiency in the family
Exclusion
- The patient was diagnosed with ADA enzyme deficiency before being included in the study,
- Congenital bronchiectasis before inclusion in the study (cystic fibrosis, primary ciliary dyskinesia,alpha-1 anti trypsin deficiency, etc. diagnosed,
- Having used drugs that may cause lymphopenia before being included in the study (chemotherapy, cytotoxic drug use, etc.),
- The Ministry of Health COVID-19 diagnosis guide (nazofaringeal, nasal orofaringiyal or SARS-CoV-2 RNA PCR test and/or tomographic) as COVID-19, diagnosed and/or persons who had contact with patients diagnosed in this manner, even karsilasal patient recruitment criteria, these patients will be taken after PCR tests were negative in the study.
- Before being included in the study, it should be noted that other diseases that can cause lymphopenia (hematological diseases, oncological diseases, etc.) have been diagnosed with,
- The patient has participated in an interventional clinical trial within the last 30 days,
- Conclusion-In the opinion of the researcher, the patient will not be able to properly fulfill the study requirements,
- Pregnancy-the period of pregnancy and/or lactation,
- The fact that the volunteer participating in the study received an erythrocyte suspension or a complete blood transfusion within the last 3 months.
Key Trial Info
Start Date :
June 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 17 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05300347
Start Date
June 17 2021
End Date
June 17 2023
Last Update
March 29 2022
Active Locations (1)
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1
Ankara University Medical Faculty
Ankara, Mamak, Turkey (Türkiye)