Adenosine Deaminase DeficiencyNCT05300334
Investigation of ADA Enzyme Deficiency
An observational study of Adenosine Deaminase Deficiency, run by TRPHARM at 1 site in Turkey (Türkiye).
Trial summary
This observational study was designed as a prospective epidemiological screening study. Patients who applied to the centers participating in the study and were found to be lymphopenic in at least one examination will be included in the study. Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Adenosine Deaminase Deficiency
- What is being tested?
- adenosine deaminase test
- How many people
- 800 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2019to 10 Oct 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 Up to 40 years
- All sexes
- Child, Adult
Study population: 1. The presence of lymphopenia as a result of at least one hemogram of the patient, * The number of lymphocytes should be below 3000/mm3 for the first 0-12 months * The number of lymphocytes dec below 1500/mm3 for the first 13 months- ≤ 40 years 2. The patient should be 0- ≤ 40 years of age
Who may be able to join
- Signing of the written informed consent form by the patient and/or his legal representative,
- The presence of lymphopenia as a result of at least one hemogram of the patient,
- The number of lymphocytes should be below 3000/mm3 for the first 0-12 months
- The number of lymphocytes dec below 1500/mm3 for the first 13 months- ≤ 40 years
- The patient should be 0- ≤ 40 years of age
Who cannot join
- The patient was diagnosed with ADA enzyme deficiency before being included in the study,
- The patient has participated in an interventional clinical trial within the last 30 days,
- Failure of the patient himself and/or his legal representative to 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
Ankara Üniversitesi Tıp Fakültesi
Ankara, Mamak
About this study
Official title: Prospective Observational Study Evaluating the Prevalence of Adenosine Deaminase (ADA) Enzyme Deficiency Disease in Lymphopenic Patients in Immunology Clinics
This observational study was designed as a prospective epidemiological screening study. Patients who applied to the centers participating in the study and were found to be lymphopenic in at least one examination 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 will be taken from patients on Guthrie paper. The blood taken will be sent to the Duzen Laboratories center located in Ankara and will be subjected to ADA metabolites analysis. For patients with a high metabolic test, the responsible investigator 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 in patients with lymphopenia will be evaluated. In addition, with this study, it will be scientifically demonstrated whether lymphopenia is a parameter that facilitates early diagnosis of ADA patients.
Read the detailed description
Primary immune deficiencies present with signs and symptoms concerning the various disciplines of medicine when compared to other communities in our country on a more frequent basis and are determined severe combined immune deficiencies; T, B and NK cell development occasionally and/or errors caused by inherited genes that play a role in function, the immune system is a group of diseases of heterogeneous dysfunction that creates serious. 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. Each step that is active in the emergence of an immune response creates the potential for a primary immunodeficiency disease. Due to the development of molecular and cellular techniques, the possibility of prenatal diagnosis has arisen with the detection of localization and mutations of the defective gene in various immunodeficiencies. 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 SCID is not known in our country. Unlike in Europe and America, SCID types, which are autosomal recessive in our country, are considered to be the most common form due to high rates of inbreeding. The figure obtained by comparing the number of live babies born in a year in Konya with the number of SCID cases diagnosed in the Pediatric Immunology clinic of the Meram Faculty of Medicine of Selcuk University, the only primary immunodeficiency diagnostic center in the region, in the same year, is 1/10,000. This preliminary study shows that in our country this disease is much more common than in Europe and America. Based on the fact that about 1,400,000 babies are born per year in our country it should be expected that 140 new cases of SCID should be encountered every year. The number of cases diagnosed in our country is much lower than this figure. 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. A high percentage of dATP accumulates in ADA deficiency, 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, 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. 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). 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. Although studies are continuing for SCID, which has not yet been included in the screening program in our country, the tandem mass spectrometer, which can be used to diagnose ADA deficiency, is used in newborn screening programs for metabolic diseases. Studies of newborn screening with a tandem mass spectrometer for ADA and PNP deficiencies, which is also a metabolic disease, began after 2010, and it has been shown that this method is a low-cost and reliable method. Early and late onset ADA deficiency cases can be detected with sensitivity and specificity reaching 100% with this method. Importance of early diagnosis: In Early Onset ADA deficiency, patients usually consult a doctor with signs of infections. The fact that infections are already common in the dairy childhood age group makes diagnosis difficult. If there is no similar case in the family that has been diagnosed before, or if this is not paid attention to in the history, the diagnosis of the cases is delayed. In late-onset ADA deficiency, the diagnosis is much more difficult. Low awareness of the disease and its symptoms usually results in these cases not being able to get a diagnosis, not being able to get effective treatment, and organ damage. For this reason, early diagnosis is very important in terms of quality of life as well as vital importance.
Grounds:
Data on the frequency of ADA enzyme deficiency in primary immunodeficiencies are insufficient. 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 early diagnosis and obtain preliminary data on the prevalence of ADA disease by looking at ADA metabolites in the target patient group with lymphopenia and obtaining preliminary data on the prevalence of ADA disease.
- Conditions
- Adenosine Deaminase Deficiency
- Being tested
- adenosine deaminase test
- Keywords
- lymphopenia, adenosine deaminase, guithre paper
- Medical subject headings
- Severe combined immunodeficiency due to adenosine deaminase deficiency, Lymphopenia
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 deficiency test
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of patients with a high ADA metabolite test to patients with lymphopenia
The proportion of patients with lymphopenia who have an ADA metabolite test above the threshold and are suspected of having an ADA enzyme deficiency
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 posted29 Mar 2022
- Study start10 Oct 2019
- Primary completion5 Nov 2020
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenosine Deaminase DeficiencyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRPHARM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300334
- Sponsor's protocol ID
- TR-ADA-002
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Evaluating the Prevalence of Adenosine Deaminase (ADA) Enzyme Deficiency Disease in Lymphopenic Patients in Immunology Clinics
- ClinicalTrials.gov ID
- NCT05300334
- Acronym / sponsor ID
- TR-ADA-002
- Conditions
- Adenosine Deaminase Deficiency
- Keywords
- lymphopenia, adenosine deaminase, guithre paper
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- TRPHARMIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 29 Mar 2022 (actual)
- 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.
This observational study was designed as a prospective epidemiological screening study. Patients who applied to the centers participating in the study and were found to be lymphopenic in at least one examination 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 will be taken from patients on Guthrie paper. The blood taken will be sent to the Duzen Laboratories center located in Ankara and will be subjected to ADA metabolites analysis. For patients with a high metabolic test, the responsible investigator 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 in patients with lymphopenia will be evaluated. In addition, with this study, it will be scientifically demonstrated whether lymphopenia is a parameter that facilitates early diagnosis of ADA patients.
Detailed description
Primary immune deficiencies present with signs and symptoms concerning the various disciplines of medicine when compared to other communities in our country on a more frequent basis and are determined severe combined immune deficiencies; T, B and NK cell development occasionally and/or errors caused by inherited genes that play a role in function, the immune system is a group of diseases of heterogeneous dysfunction that creates serious. 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. Each step that is active in the emergence of an immune response creates the potential for a primary immunodeficiency disease. Due to the development of molecular and cellular techniques, the possibility of prenatal diagnosis has arisen with the detection of localization and mutations of the defective gene in various immunodeficiencies. 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 SCID is not known in our country. Unlike in Europe and America, SCID types, which are autosomal recessive in our country, are considered to be the most common form due to high rates of inbreeding. The figure obtained by comparing the number of live babies born in a year in Konya with the number of SCID cases diagnosed in the Pediatric Immunology clinic of the Meram Faculty of Medicine of Selcuk University, the only primary immunodeficiency diagnostic center in the region, in the same year, is 1/10,000. This preliminary study shows that in our country this disease is much more common than in Europe and America. Based on the fact that about 1,400,000 babies are born per year in our country it should be expected that 140 new cases of SCID should be encountered every year. The number of cases diagnosed in our country is much lower than this figure. 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. A high percentage of dATP accumulates in ADA deficiency, 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, 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. 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). 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. Although studies are continuing for SCID, which has not yet been included in the screening program in our country, the tandem mass spectrometer, which can be used to diagnose ADA deficiency, is used in newborn screening programs for metabolic diseases. Studies of newborn screening with a tandem mass spectrometer for ADA and PNP deficiencies, which is also a metabolic disease, began after 2010, and it has been shown that this method is a low-cost and reliable method. Early and late onset ADA deficiency cases can be detected with sensitivity and specificity reaching 100% with this method. Importance of early diagnosis: In Early Onset ADA deficiency, patients usually consult a doctor with signs of infections. The fact that infections are already common in the dairy childhood age group makes diagnosis difficult. If there is no similar case in the family that has been diagnosed before, or if this is not paid attention to in the history, the diagnosis of the cases is delayed. In late-onset ADA deficiency, the diagnosis is much more difficult. Low awareness of the disease and its symptoms usually results in these cases not being able to get a diagnosis, not being able to get effective treatment, and organ damage. For this reason, early diagnosis is very important in terms of quality of life as well as vital importance.
Grounds:
Data on the frequency of ADA enzyme deficiency in primary immunodeficiencies are insufficient. 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 early diagnosis and obtain preliminary data on the prevalence of ADA disease by looking at ADA metabolites in the target patient group with lymphopenia and obtaining preliminary data on the prevalence of ADA disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 1. The presence of lymphopenia as a result of at least one hemogram of the patient, * The number of lymphocytes should be below 3000/mm3 for the first 0-12 months * The number of lymphocytes dec below 1500/mm3 for the first 13 months- ≤ 40 years 2. The patient should be 0- ≤ 40 years of age
Key inclusion criteria (5 listed)
- Signing of the written informed consent form by the patient and/or his legal representative,
- The presence of lymphopenia as a result of at least one hemogram of the patient,
- The patient should be 0- ≤ 40 years of age
Key exclusion criteria (6 listed)
- The patient was diagnosed with ADA enzyme deficiency before being included in the study,
- The patient has participated in an interventional clinical trial within the last 30 days,
- Failure of the patient himself and/or his legal representative to 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adenosine deaminase testadenosine deaminase deficiency test | Diagnostic test | – |
Primary outcome
The ratio of patients with a high ADA metabolite test to patients with lymphopenia
Time frame: 2 years
The proportion of patients with lymphopenia who have an ADA metabolite test above the threshold and are suspected of having an ADA enzyme deficiency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adenosine Deaminase Deficiency, 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 5 inclusion and 6 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 ratio of patients with a high ADA metabolite test to patients with lymphopenia (time frame: 2 years). 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.