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Pulmonary Alveolar ProteinosisNCT05300360

Prevalence of Adenosine Deaminase (ADA) Enzyme Deficiency Disease in Adult Patients With Pulmonary Alveolar Proteinosis

An observational study of Pulmonary Alveolar Proteinosis, run by TRPHARM at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This observational study was designed as a prospective epidemiological screening study. Patients who have applied to the centers participating in the study and who have previously been clinically or pathologically diagnosed with PAP (Pulmonary alveolar proteinosis) will be included in the study. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pulmonary Alveolar Proteinosis
What is being tested?
adenosine deaminase test
How many people
15 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Aug 2021to 16 Aug 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: male and female patients aged 18-70

Who may be able to join

  • Signing of the written informed consent form by the patient and/or his legal representative,
  • The patient should be between the ages of 18 and 70,
  • Diagnosis of PAP: The patient has been diagnosed with PAP clinically or histologically.

Who cannot join

  • The patient was diagnosed with ADA enzyme deficiency before being included in the study,
  • The patient's PAP diagnosis is secondary to an occupational disease such as silicosis,
  • The patient's PAP diagnosis is secondary to an oncological disease,
  • The patient has participated in an interventional clinical trial within the last 30 days,
  • The patient himself and/or his legal representative did not give their consent to participate in the study,
  • According to the researcher's opinion, the patient will not be able to properly fulfill the study requirements,
  • Pregnancy and/or lactation period,
  • The fact that the volunteer participating in the study received an erythrocyte suspension or a complete blood transfusion within the last 3 months.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

    Istanbul, Maltepe

Other trials in Turkey (Türkiye)

About this study

Official title: Prospective Observational Study Evaluating the Prevalence of Adenosine Deaminase (ADA) Enzyme Deficiency Disease in Adult Patients With Pulmonary Alveolar Proteinosis in Pulmonology Clinics

This observational study was designed as a prospective epidemiological screening study. Patients who have applied to the centers participating in the study and who have previously been clinically or pathologically diagnosed with PAP (Pulmonary alveolar proteinosis) will be included in the study. Up-to-date data will be collected from patients who have agreed to participate in the study, and a blood sample with DBS will be taken from patients. The blood taken will be subjected to analysis for ADA metabolites. For patients with a high metabolic test, the responsible researcher will advise on clarifying the diagnosis with a genetic test other than the study. In case of formation of new information for each patient, consultation will be provided by the responsible researcher. Thus, the prevalence of ADA enzyme deficiency disease will be evaluated in patients diagnosed with PAP.

Read the detailed description

PAP (Pulmonary alveolar proteinosis) is a rare disease with a frequency of 0.36 per million. As a result of intensive accumulation of surfactant components in the lungs, it leads to respiratory distress at various levels. PAP has been frequently monitored among patients with ADA enzyme deciency. Primary immunodeficiency diseases are a group of diseases that are accompanied by chronic and/or recurrent bacterial, fungal, protozoal and viral infections that develop as a result of primary or congenital immunodeficiency. The incidence dec in society varies from 1/10,000 to 1/100,000. Combined immunodeficiencies account for 15-29% of primary immunodeficiencies. Severe Combined Immunodeficiencies (SCID) are a heterogeneous group of diseases caused by hereditary errors in genes involved in the development and/or function of T, B, and sometimes NK cells, which cause serious dysfunction of the immune system. The incidence is estimated at 1/100,000 live births in the United States. Although the exact incidence of inbreeding is not known in our country, where inbreeding is common, it is expected that those who show autosomal recessive transition will be more common, especially. The recognition of these disorders by clinicians is important for reducing long-term complications due to recurrent infections and preventing mortality with appropriate treatment. The frequency of SCIDY in our country is unknown. Unlike in Europe and America, SCID types, which are autosomal recessive in our country, are considered to be the most common form due to the high rates of inbreeding. The ratio obtained by comparing the number of live babies born in a year in Konya with the number of SCID cases diagnosed in the same year in the Pediatric Immunology Clinic of the Meram Faculty of Medicine of Selcuk University, the only primary immunodeficiency diagnostic center in the region, is 1/10,000. This preliminary study shows that in our country this disease is much more common than in Europe and America. To date, more than 20 genetic defects have been identified that cause SCID. All known genetic defects disrupt the development of cells of the immune system, causing combined immunodeficiency. One of them, the ADA defect, is also a metabolic disease, due to which there is a lack of enzymes. ADA catalyzes the deamination of purine nucleosides adenosine (Ado) and 2'-deoxyadenosine (dAdo), which are produced during the degradation and transformation of RNA and DNA. ADA is a cleansing enzyme: it detoxifies purines. In ADA deficiency, 2'-deoxyadenosine (dAdo) is phosphorylated and converted into deoxyadenosine triphosphate (dATP). Accumulation of DATP disrupts DNA repair and replication. In ADA deficiency, a high percentage of dATP accumulates, especially in erythrocytes and lymphocytes. Increased levels of adenosine break down the wall of the lymphocyte. It inhibits the development of lymphocytes in the thymus. A kind of lymphocyte intoxication occurs. It leads to a severe form of lymphopenia. Approximately 10-20% of SCID are diagnosed as ADA enzyme deficiency. It shows an autosomal recessive transition. Your gene is 20. it is localized on the long arm of the chromosome.

Clinically, there are early and late onset types:

Classic-early onset ADA deficiency: Although normal at birth, patients present with infections seen from the first months of life, resulting in death if left untreated. In addition to the AKI table, neuro-developmental disorders, sensorineural hearing loss and/or skeletal abnormalities have also been reported in these patients. Although hematopoietic stem cell transplantation, enzyme replacement therapy and gene therapy are treatment approaches that provide cure, early diagnosis determines the prognosis.

Late-onset ADA deficiency: Patients may present with recurrent infections, bronchiectasis, autoimmunity, human papillomavirus (HPV) infections at an older age, even in adulthood. Lymphopenia is an invariable finding. High IgE and eosinophilia may be observed. In these cases, residual enzyme activity due to the type of mutation causes a late onset. This phenotype accounts for 10-15% of all cases of ADA deficiency.

Patients with late-onset ADA enzyme deficiency appear in the form of case reports. in a study in which the data of two patients were shared in Zurich in 1997, one patient had a history of recurrent otitis and pulmonary infection, bronchiectasis, lymphopenia, and immunoglobulin E elevation. The other patient, his cousin ADA, was diagnosed by chance while undergoing a bone marrow scan due to enzyme deficiency. He had a history of recurrent tonsillitis.

In a study conducted by Hacettepe University published in 2018. The data of 13 ADA enzyme deficient patients were evaluated and it was determined that 3 patients with late/delayed diagnosis had ADA enzyme deficiency. A patient with a late diagnosis of ADA enzyme deficiency was found to have recurrent pneumonia, bronchiectasis, and immunoglobulin E elevation.

In the study in which the data of a patient with a late onset ADA enzyme deficiency published in Konya from our country in 2010 were shared, it was observed that the patient had a history of resection of the lower left lobe due to bronchiectasis, lymphopenia and an increase in immunoglobulin E.

Diagnosis: ADA enzyme deficiency is included in severe combined immunodeficiencies and is observed with lymphopenia and infections. The diagnosis is made by measuring the activity of the enzyme ADA in erythrocytes or lymphocytes in patients with suspected clinical and laboratory features (such as lymphopenia, bronchiectasis). By mutation analysis, a gene defect is shown. However, T-cell receptor excision circles (TREC) test is used for early diagnosis. However, since the TREC test is found to be normal at birth in late-onset patients, screening that leads patients to an early diagnosis can only be achieved by measuring ADA metabolites.

In late-onset ADA deficiency, it is difficult to diagnose. Low awareness of the disease and its symptoms usually results in these cases not being diagnosed, not being able to reach effective treatment, permanent organ damage and patient loss. For this reason, diagnosis of patients is very important in terms of quality of life, as well as vital importance.

Reason ADA enzyme deficiencies account for approximately 15% of severe combined immunodeficiencies. In 15-20% of patients with ADA enzyme deficiency, ADA enzyme deficiency is observed with a late diagnosis. Because of the inability of these patients to get a diagnosis, their treatment is also inadequate. For the first time in our country, this study aims to determine the diagnosis and obtain preliminary data on the prevalence of ADA disease by looking at ADA metabolites in a group of adult patients diagnosed with PAP.

Being tested
adenosine deaminase test
Keywords
Pulmonary Alveolar Proteinosis, adenosine deaminase, guithre paper
Medical subject headings
Pulmonary Alveolar Proteinosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adenosine deaminase testDiagnostic test

    adenosine deaminase enzyme deficiency test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of ADA enzyme deficiency in PAP patients

    The proportion of adult patients with PAP who are above the ADA metabolite test threshold and are suspected of having ADA enzyme deficiency.

    Measured: six months

Secondary outcomes (7)
  1. e ratio of PAP and ADA enzyme deficiency

    The relationship between the level and frequency of lymphopenia and ADA enzyme dec disease

    Measured: 6 months

  2. The relationship between lymphopenia and ADA enzyme deficiency

    The relationship between the level and frequency of lymphopenia and ADA enzyme deciency disease

    Measured: 6 months

  3. graphic parameters with lymphopenia

    The relationship between lymphopenia and demograpfic parameters

    Measured: 6 months

  4. Family history and ADA

    Family history of immunodeficiency/ADA

    Measured: 6 months

  5. The presence of inbreeding and the relationship of adenosine deaminase

    The presence of inbreeding

    Measured: 6 months

  6. The rate of late ADA enzyme deficiency disease

    The rate of late ADA enzyme deficiency disease

    Measured: 6 months

  7. infection frequency and ADA enzyme deficiency

    The relationship between infection frequency and ADA enzyme deficiency

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2022
  2. Study start16 Aug 2021
  3. Primary completion16 Sep 2021
  4. Study completion16 Aug 2022 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05300360
Sponsor's protocol ID
TR-ADA-006
Status last verified
Mar 2022
First submitted
18 Mar 2022
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Alveolar Proteinosis, run by TRPHARM at 1 site in Turkey (Türkiye).

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 3 inclusion and 8 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 29 Mar 2022. 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 Turkey (Türkiye). 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of ADA enzyme deficiency in PAP patients (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Mar 2022.

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