Cerebrotendinous XanthomatosisGEN-EYE-INCT03584893
The Prevalence of CTX Disorder in Juvenile Cataract Cases in Turkey
An observational study of Cerebrotendinous Xanthomatosis, run by TRPHARM at 36 sites in Turkey (Türkiye).
Trial summary
Epidemiologic observational study. Study will include two phases: 1. Retrospective cross-sectional phase: At this stage of the study, retrospective screenings are carried out at study sites and all juvenile cataract cases are planned to be determined. 2. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cerebrotendinous Xanthomatosis
- What is being tested?
- Blood sampling for Cholestanol Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 36 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Mar 2023
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients over 1 year old diagnosed as idiopathic bilateral juvenile cataracts will be included in the study at the study sites.
Who may be able to join
- Providing the written informed consent form
- The patient should be diagnosed with idiopathic bilateral juvenile cataract
- Idiopathic bilateral juvenile cataract should be diagnosed while the patient must be take a day from one year (age)
- Syria ciziten who take their citizenship of Turkey could be enrolled to the study after signing of Informed Consent Form that translated to mother tongue by sworn translation office approved by ethic committee.
Who cannot join
- If the patient has been diagnosed with CTX before his/her enrollment in the study,
- If the patient has been diagnosed with cataract due to any known reasons other than CTX including cataracts related to trauma,
- If the patient has been diagnosed with cataract due to cataractogenic treatments,
- If the patient has participated in an interventional clinical study within the last 30 days,
- If the patient and/or his/her legal representative does not provide consent to participate in the study,
- If the patient will not be able to fulfill study requirements according to the investigator's opinion,
Show all 9Show fewer
- If the patient had used cholic acid or chenodeoxycholic acid on or before the date of participation in the study
- Pregnancy and/or lactation
- Syria citizen that have not Turkey citizenship will not enroll to the study.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Turkey (Türkiye)36 sites, 33 recruiting
- Not yet recruiting
Adana Başkent University School of Medicine
Adana
Aysel Pelit
- Recruiting
Adana State Hospital
Adana
- Recruiting
Çukurova University Medical Faculty Department of Ophtalmology
Adana
- Recruiting
Ankara Training and Research Hospital
Ankara
- Recruiting
Ankara University Medical Faculty Department of Ophtalmology
Ankara
- Recruiting
Başkent University School of Medicine
Ankara
- Recruiting
Dünya Göz Hospital
Ankara
- Recruiting
Hacettepe University Medical Faculty Department of Ophtalmology
Ankara
- Recruiting
Health Sciences University Ankara State Hospital
Ankara
- Recruiting
SBU Gülhane Training and Research Hospital
Ankara
- Recruiting
Ulucanlar Göz Training Hospital
Ankara
- Recruiting
Akdeniz University Medical Faculty Department of Ophtalmology
Antalya
- Recruiting
Bursa Yüksek İhtisas Training and Research Hospital
Bursa
- Terminated
Uludağ University Medical Faculty Department of Ophtalmology
Bursa
- Terminated
Dicle University School of Medicine
Diyarbakır
- Recruiting
Fırat University School of Medicine
Elâzığ
- Recruiting
Osmangazi University Medical Faculty Department of Ophtalmology
Eskişehir
- Recruiting
Gaziantep University Şahinbey Training and Research Hospital
Gaziantep
- Recruiting
Istanbul University Istanbul Medical Faculty Department of Ophtalmology
Istanbul
- Recruiting
İstanbul Haseki Training and Research Hospital
Istanbul
Nilgün Solmaz
- Recruiting
İstanbul Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital
Istanbul
- Recruiting
Marmara University Medical Faculty Department of Ophtalmology
Istanbul
- Not yet recruiting
Marmara University Pendik Training and Research Hospital
Istanbul
Eren Çerman
- Recruiting
Prof.Dr.N.Reşat Belger Beyoğlu Göz Training and Research Hospital
Istanbul
- Recruiting
Dokuz Eylül University Medical Faculty Department of Ophtalmology
Izmir
- Recruiting
Ege University Medical Faculty Department of Ophtalmology
Izmir
- Recruiting
İzmir Dr. Behcet Uz Child Diseases and Surgery Training and Research Hospital
Izmir
- Recruiting
Kayseri Training and Research Hospital
Kayseri
- Recruiting
Kocaeli University School of medicine
Kocaeli
Dilara Pirhan
- Terminated
İnönü University School of Medicine
Malatya
- Recruiting
Mersin University Medical Faculty Department of Ophtalmology
Mersin
- Recruiting
Sakarya University School of Medicine
Sakarya
Erkan Çelik
- Recruiting
Ondokuz Mayıs University School of Medicine
Samsun
- Recruiting
Harran University Research and Application Hospital
Sanliurfa
- Recruiting
Karadeniz Technical University School of Medicine
Trabzon
- Recruiting
Van 100. Yıl University Dursun Odabaş Medical Center
Van
About this study
Official title: An Observational Study With Retrospective and Prospective Evaluations to Determine the Prevalence of Cerebrotendinous Xanthomatosis (CTX) Disorder in Juvenile Cataract Cases in Turkey
Epidemiologic observational study. Study will include two phases:
- Retrospective cross-sectional phase: At this stage of the study, retrospective screenings are carried out at study sites and all juvenile cataract cases are planned to be determined.
- Prospective phase: At this stage of the study, identified juvenile cataract cases as a result of retrospective screenings will be called to be invited to the sites and blood samples will be obtained for the cholestanol tests for the cases that have given Informed Consent.
This observational study is designed in two phases; retrospective and prospective. Retrospective part includes screening the patient database and / or patient files at ophthalmology clinics participating in the study and identifying patients diagnosed with idiopathic juvenile cataracts. The data of patients with idiopathic juvenile cataracts will be reviewed and the data of the patients meeting the inclusion/exclusion criteria will be recorded. Once this phase is completed, the prospective phase of the study will start and the patients meeting the criteria will be invited to the site to participate in the study. Current data will be collected from the patients who agree to participate in the study and the clinical status of the patients will be evaluated according to the Mignarri index. In addition, blood will be obtained from all patients to diagnose CTX disease. Blood samples will be sent to Duzen Laboratories in Ankara and analyzed for cholestanol.
- Conditions
- Cerebrotendinous Xanthomatosis
- Being tested
- Blood sampling for Cholestanol Analysis
- Keywords
- Juvenile Cataract, CTX, Diarrhea, Neonatal Jaundice, Xanthoma
- Medical subject headings
- Xanthomatosis, Cerebrotendinous, Diarrhea, Jaundice, Neonatal, Xanthomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for Cholestanol AnalysisProcedure or surgery
Cholestanol analysis will be performed to see the Rate of juvenile cataract patients whose cholestanol test result is above threshold (3.75 mg/mL) and suspected CTX cases
| Study group | Role | What they receive |
|---|---|---|
| Epidemiologic observational study cohort | All patients over 1 year old diagnosed as idiopathic bilateral juvenile cataracts will be included in the study at the study sites. Receives: Procedure: Blood sampling for Cholestanol Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of juvenile cataract patients
Rate of juvenile cataract patients whose cholestanol test result is above threshold (3.75 mg/mL) and suspected CTX cases
Measured: "through study completion, an average of 3 years"
Secondary outcomes (4)
CTX history in family
The history of the disease will be assessed from the patient records and by interview
Measured: "through study completion, an average of 3 years"
Presence of consanguineous marriage
Presence of consanguineous marriage
Measured: "through study completion, an average of 3 years"
The frequency of the systemic findings
The frequency of the following systemic findings:
- Tendon xanthomas
- Chronic diarrhea
- Prolonged neonatal jaundice
- Early osteoporosis
Measured: "through study completion, an average of 3 years"
The frequency of the neurological symptoms
The frequency of the following neurological symptoms:
- Cerebellar ataxia
- Spastic paraparesis
- Disruption of dentate nucleus signal detected by MRI
- Intellectual disability
- Psychiatric disorders
- Epilepsy
- Parkinson
- Polyneuropathy
Measured: "through study completion, an average of 3 years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cerebrotendinous XanthomatosisStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRPHARM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinar CRO, Düzen Laboratories Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584893
- Sponsor's protocol ID
- TR-CTX-001
- Acronym
- GEN-EYE-I
- Status last verified
- Mar 2021
- First submitted
- 19 Jun 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clayton PT (2016) Disorders of Bile Acid Synthesis. In: Saudubray JM, Baumgartner MR, Walter J (eds) Inborn metabolic diseases: diagnosis and treatment, 6th ed. Springer-Verlag, Heidelberg, pp 465- 477
Nie S, Chen G, Cao X, Zhang Y. Cerebrotendinous xanthomatosis: a comprehensive review of pathogenesis, clinical manifestations, diagnosis, and management. Orphanet J Rare Dis. 2014 Nov 26;9:179. doi: 10.1186/s13023-014-0179-4.
PubMed 25424010Federico A, Gallus GN. Cerebrotendinous Xanthomatosis. 2003 Jul 16 [updated 2024 Nov 14]. In: Adam MP, Bick S, Mirzaa GM, Pagon RA, Wallace SE, Amemiya A, editors. GeneReviews(R) [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2026. Available from http://www.ncbi.nlm.nih.gov/books/NBK1409/
PubMed 20301583Fraidakis MJ. Psychiatric manifestations in cerebrotendinous xanthomatosis. Transl Psychiatry. 2013 Sep 3;3(9):e302. doi: 10.1038/tp.2013.76.
PubMed 24002088Cruysberg JR, Wevers RA, Tolboom JJ. Juvenile cataract associated with chronic diarrhea in pediatric cerebrotendinous xanthomatosis. Am J Ophthalmol. 1991 Nov 15;112(5):606-7. doi: 10.1016/s0002-9394(14)76874-6. No abstract available.
PubMed 1951610Mignarri A, Gallus GN, Dotti MT, Federico A. A suspicion index for early diagnosis and treatment of cerebrotendinous xanthomatosis. J Inherit Metab Dis. 2014 May;37(3):421-9. doi: 10.1007/s10545-013-9674-3. Epub 2014 Jan 18.
PubMed 24442603Verrips A, Hoefsloot LH, Steenbergen GC, Theelen JP, Wevers RA, Gabreels FJ, van Engelen BG, van den Heuvel LP. Clinical and molecular genetic characteristics of patients with cerebrotendinous xanthomatosis. Brain. 2000 May;123 ( Pt 5):908-19. doi: 10.1093/brain/123.5.908.
PubMed 10775536Salen G, Steiner RD. Epidemiology, diagnosis, and treatment of cerebrotendinous xanthomatosis (CTX). J Inherit Metab Dis. 2017 Nov;40(6):771-781. doi: 10.1007/s10545-017-0093-8. Epub 2017 Oct 4.
PubMed 28980151Cali JJ, Hsieh CL, Francke U, Russell DW. Mutations in the bile acid biosynthetic enzyme sterol 27-hydroxylase underlie cerebrotendinous xanthomatosis. J Biol Chem. 1991 Apr 25;266(12):7779-83.
PubMed 2019602Yahalom G, Tsabari R, Molshatzki N, Ephraty L, Cohen H, Hassin-Baer S. Neurological outcome in cerebrotendinous xanthomatosis treated with chenodeoxycholic acid: early versus late diagnosis. Clin Neuropharmacol. 2013 May-Jun;36(3):78-83. doi: 10.1097/WNF.0b013e318288076a.
PubMed 23673909Khan AO, Aldahmesh MA, Mohamed JY, Alkuraya FS. Juvenile cataract morphology in 3 siblings not yet diagnosed with cerebrotendinous xanthomatosis. Ophthalmology. 2013 May;120(5):956-60. doi: 10.1016/j.ophtha.2012.10.032. Epub 2013 Jan 31.
PubMed 23375591
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study With Retrospective and Prospective Evaluations to Determine the Prevalence of Cerebrotendinous Xanthomatosis (CTX) Disorder in Juvenile Cataract Cases in Turkey
- ClinicalTrials.gov ID
- NCT03584893
- Acronym / sponsor ID
- GEN-EYE-I / TR-CTX-001
- Conditions
- Cerebrotendinous Xanthomatosis
- Keywords
- Juvenile Cataract, CTX, Diarrhea, Neonatal Jaundice, Xanthoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- TRPHARMIndustry (pharma, biotech, devices)
- Collaborators
- Klinar CRO, Düzen Laboratories Group
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 12 Jul 2018 (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.
Epidemiologic observational study. Study will include two phases:
- Retrospective cross-sectional phase: At this stage of the study, retrospective screenings are carried out at study sites and all juvenile cataract cases are planned to be determined.
- Prospective phase: At this stage of the study, identified juvenile cataract cases as a result of retrospective screenings will be called to be invited to the sites and blood samples will be obtained for the cholestanol tests for the cases that have given Informed Consent.
This observational study is designed in two phases; retrospective and prospective. Retrospective part includes screening the patient database and / or patient files at ophthalmology clinics participating in the study and identifying patients diagnosed with idiopathic juvenile cataracts. The data of patients with idiopathic juvenile cataracts will be reviewed and the data of the patients meeting the inclusion/exclusion criteria will be recorded. Once this phase is completed, the prospective phase of the study will start and the patients meeting the criteria will be invited to the site to participate in the study. Current data will be collected from the patients who agree to participate in the study and the clinical status of the patients will be evaluated according to the Mignarri index. In addition, blood will be obtained from all patients to diagnose CTX disease. Blood samples will be sent to Duzen Laboratories in Ankara and analyzed for cholestanol.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidemiologic observational study cohort | – | Procedure: Blood sampling for Cholestanol AnalysisAll patients over 1 year old diagnosed as idiopathic bilateral juvenile cataracts will be included in the study at the study sites. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients over 1 year old diagnosed as idiopathic bilateral juvenile cataracts will be included in the study at the study sites.
Key inclusion criteria (4 listed)
- Providing the written informed consent form
- The patient should be diagnosed with idiopathic bilateral juvenile cataract
- Idiopathic bilateral juvenile cataract should be diagnosed while the patient must be take a day from one year (age)
- Syria ciziten who take their citizenship of Turkey could be enrolled to the study after signing of Informed Consent Form that translated to mother tongue by sworn translation office approved by ethic committee.
Key exclusion criteria (9 listed)
- If the patient has been diagnosed with CTX before his/her enrollment in the study,
- If the patient has been diagnosed with cataract due to any known reasons other than CTX including cataracts related to trauma,
- If the patient has been diagnosed with cataract due to cataractogenic treatments,
- If the patient has participated in an interventional clinical study within the last 30 days,
- If the patient and/or his/her legal representative does not provide consent to participate in the study,
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 |
|---|---|---|
| Blood sampling for Cholestanol AnalysisCholestanol analysis will be performed to see the Rate of juvenile cataract patients whose cholestanol test result is above threshold (3.75 mg/mL) and suspected CTX cases | Procedure or surgery | Epidemiologic observational study cohort |
Primary outcome
Rate of juvenile cataract patients
Time frame: "through study completion, an average of 3 years"
Rate of juvenile cataract patients whose cholestanol test result is above threshold (3.75 mg/mL) and suspected CTX cases
4 secondary outcomes
CTX history in family
Time frame: "through study completion, an average of 3 years"
Presence of consanguineous marriage
Time frame: "through study completion, an average of 3 years"
The frequency of the systemic findings
Time frame: "through study completion, an average of 3 years"
The frequency of the neurological symptoms
Time frame: "through study completion, an average of 3 years"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- BackgroundClayton PT (2016) Disorders of Bile Acid Synthesis. In: Saudubray JM, Baumgartner MR, Walter J (eds) Inborn metabolic diseases: diagnosis and treatment, 6th ed. Springer-Verlag, Heidelberg, pp 465- 477
- Background: PubMed 25424010Nie S, Chen G, Cao X, Zhang Y. Cerebrotendinous xanthomatosis: a comprehensive review of pathogenesis, clinical manifestations, diagnosis, and management. Orphanet J Rare Dis. 2014 Nov 26;9:179. doi: 10.1186/s13023-014-0179-4.
- Background: PubMed 20301583Federico A, Gallus GN. Cerebrotendinous Xanthomatosis. 2003 Jul 16 [updated 2024 Nov 14]. In: Adam MP, Bick S, Mirzaa GM, Pagon RA, Wallace SE, Amemiya A, editors. GeneReviews(R) [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2026. Available from http://www.ncbi.nlm.nih.gov/books/NBK1409/
- Background: PubMed 24002088Fraidakis MJ. Psychiatric manifestations in cerebrotendinous xanthomatosis. Transl Psychiatry. 2013 Sep 3;3(9):e302. doi: 10.1038/tp.2013.76.
- Background: PubMed 1951610Cruysberg JR, Wevers RA, Tolboom JJ. Juvenile cataract associated with chronic diarrhea in pediatric cerebrotendinous xanthomatosis. Am J Ophthalmol. 1991 Nov 15;112(5):606-7. doi: 10.1016/s0002-9394(14)76874-6. No abstract available.
- Background: PubMed 24442603Mignarri A, Gallus GN, Dotti MT, Federico A. A suspicion index for early diagnosis and treatment of cerebrotendinous xanthomatosis. J Inherit Metab Dis. 2014 May;37(3):421-9. doi: 10.1007/s10545-013-9674-3. Epub 2014 Jan 18.
- Background: PubMed 10775536Verrips A, Hoefsloot LH, Steenbergen GC, Theelen JP, Wevers RA, Gabreels FJ, van Engelen BG, van den Heuvel LP. Clinical and molecular genetic characteristics of patients with cerebrotendinous xanthomatosis. Brain. 2000 May;123 ( Pt 5):908-19. doi: 10.1093/brain/123.5.908.
- Background: PubMed 28980151Salen G, Steiner RD. Epidemiology, diagnosis, and treatment of cerebrotendinous xanthomatosis (CTX). J Inherit Metab Dis. 2017 Nov;40(6):771-781. doi: 10.1007/s10545-017-0093-8. Epub 2017 Oct 4.
- Background: PubMed 2019602Cali JJ, Hsieh CL, Francke U, Russell DW. Mutations in the bile acid biosynthetic enzyme sterol 27-hydroxylase underlie cerebrotendinous xanthomatosis. J Biol Chem. 1991 Apr 25;266(12):7779-83.
- Background: PubMed 23673909Yahalom G, Tsabari R, Molshatzki N, Ephraty L, Cohen H, Hassin-Baer S. Neurological outcome in cerebrotendinous xanthomatosis treated with chenodeoxycholic acid: early versus late diagnosis. Clin Neuropharmacol. 2013 May-Jun;36(3):78-83. doi: 10.1097/WNF.0b013e318288076a.
- Background: PubMed 23375591Khan AO, Aldahmesh MA, Mohamed JY, Alkuraya FS. Juvenile cataract morphology in 3 siblings not yet diagnosed with cerebrotendinous xanthomatosis. Ophthalmology. 2013 May;120(5):956-60. doi: 10.1016/j.ophtha.2012.10.032. Epub 2013 Jan 31.
- Individual participant dataSharing planned: Undecided
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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.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrotendinous Xanthomatosis, run by TRPHARM at 36 sites 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 4 inclusion and 9 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 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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?
Contact Serdar Altinel (00902123863149, serdar.altinel@trpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of juvenile cataract patients (time frame: "through study completion, an average of 3 years"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584893, which also lists 11 linked publications.
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 2021.