RetinoblastomaNCT03935074
Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey
An observational study of Retinoblastoma, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Retrospective review of 5-year long term outcomes of superselective intra-arterial chemotherapy treatment in retinoblastoma in a single institute. The treatment outcomes, globe salvage rates and complications of superselective intra-arterial chemotherapy both for treating naive patients (primary treatment group) and… Read more about this study
- Who is it for?
- Ages 5 months to 7 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- intra-arterial administration of melphalan
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2016to 30 Nov 2016
- 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 5 months to 7 years
- All sexes
- Child
Study population: Patients diagnosed with retinoblastoma and who received superselective intra-arterial chemotherapy as a first line treatment or as a salvage treatment after systemic chemotherapy
Who may be able to join
- patients diagnosed with unilateral/bilateral retinoblastoma
Who cannot join
- patients with trilateral retinoblastoma
- extraoculer involvement
- patients with blood dyscrasias, bleeding and clotting disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa School of Medicine Ophthalmology Department
Istanbul, 34098
About this study
Retrospective review of 5-year long term outcomes of superselective intra-arterial chemotherapy treatment in retinoblastoma in a single institute.
The treatment outcomes, globe salvage rates and complications of superselective intra-arterial chemotherapy both for treating naive patients (primary treatment group) and for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated.
- Conditions
- Retinoblastoma
- Being tested
- intra-arterial administration of melphalan
- Keywords
- enucleation, globe salvage, superselective intra-arterial chemotherapy
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial administration of melphalanDrug
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Patients who received intra-arterial chemotherapy as a first line treatment Receives: Drug: intra-arterial administration of melphalan | |
| group 2 | Patients who received intra-arterial chemotherapy as a salvage treatment after systemic chemotherapy Receives: Drug: intra-arterial administration of melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
globe salvage
globe salvage rate after superselective intra-arterial chemotherapy treatment for retinoblastoma
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start30 Aug 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Batu Oto, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935074
- Sponsor's protocol ID
- 10136532
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Individual data sharing
- No
Publications
Saglam M, Sarici A, Anagnostakou V, Yildiz B, Kocer N, Islak C, Kizilkilic O. An alternative technique of the superselective catheterization of the ophthalmic artery for intra-arterial chemotherapy of the retinoblastoma: retrograde approach through the posterior communicating artery to the ophthalmic artery. Neuroradiology. 2014 Sep;56(9):751-4. doi: 10.1007/s00234-014-1388-1. Epub 2014 Jun 10.
PubMed 24913287
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey
- ClinicalTrials.gov ID
- NCT03935074
- Acronym / sponsor ID
- 10136532
- Conditions
- Retinoblastoma
- Keywords
- enucleation, globe salvage, superselective intra-arterial chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 2 May 2019 (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.
Retrospective review of 5-year long term outcomes of superselective intra-arterial chemotherapy treatment in retinoblastoma in a single institute.
The treatment outcomes, globe salvage rates and complications of superselective intra-arterial chemotherapy both for treating naive patients (primary treatment group) and for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Drug: intra-arterial administration of melphalanPatients who received intra-arterial chemotherapy as a first line treatment |
| group 2 | – | Drug: intra-arterial administration of melphalanPatients who received intra-arterial chemotherapy as a salvage treatment after systemic chemotherapy |
Who may qualify
- Ages
- 5 months to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients diagnosed with retinoblastoma and who received superselective intra-arterial chemotherapy as a first line treatment or as a salvage treatment after systemic chemotherapy
Key inclusion criteria (1 listed)
- patients diagnosed with unilateral/bilateral retinoblastoma
Key exclusion criteria (3 listed)
- patients with trilateral retinoblastoma
- extraoculer involvement
- patients with blood dyscrasias, bleeding and clotting disorders
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 |
|---|---|---|
| intra-arterial administration of melphalan | Drug | group 1, group 2 |
Primary outcome
globe salvage
Time frame: 2-5 years
globe salvage rate after superselective intra-arterial chemotherapy treatment for retinoblastoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Background: PubMed 24913287Saglam M, Sarici A, Anagnostakou V, Yildiz B, Kocer N, Islak C, Kizilkilic O. An alternative technique of the superselective catheterization of the ophthalmic artery for intra-arterial chemotherapy of the retinoblastoma: retrograde approach through the posterior communicating artery to the ophthalmic artery. Neuroradiology. 2014 Sep;56(9):751-4. doi: 10.1007/s00234-014-1388-1. Epub 2014 Jun 10.
- Individual participant dataSharing planned: No
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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 Retinoblastoma, run by Istanbul University - Cerrahpasa 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 6 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
globe salvage (time frame: 2-5 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 NCT03935074, which also lists 1 linked publication.
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 6 May 2019.