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出境医 / 临床实验 / Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey
Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey
Study Description
Brief 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 for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated.
| Condition or disease | Intervention/treatment |
|---|---|
| Retinoblastoma | Drug: intra-arterial administration of melphalan |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 30 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey |
| Actual Study Start Date : | August 30, 2016 |
| Actual Primary Completion Date : | November 30, 2016 |
| Actual Study Completion Date : | November 30, 2016 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
group 1
Patients who received intra-arterial chemotherapy as a first line treatment
|
Drug: intra-arterial administration of melphalan |
|
group 2
Patients who received intra-arterial chemotherapy as a salvage treatment after systemic chemotherapy
|
Drug: intra-arterial administration of melphalan |
Outcome Measures
Primary Outcome Measures :
- globe salvage [ Time Frame: 2-5 years ]globe salvage rate after superselective intra-arterial chemotherapy treatment for retinoblastoma
Eligibility Criteria
| Ages Eligible for Study: | 5 Months to 7 Years (Child) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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
Criteria
Inclusion Criteria:
- patients diagnosed with unilateral/bilateral retinoblastoma
Exclusion Criteria:
- patients with trilateral retinoblastoma
- extraoculer involvement
- patients with blood dyscrasias, bleeding and clotting disorders
Contacts and Locations
Locations
| Turkey | |
| Istanbul University Cerrahpasa School of Medicine Ophthalmology Department | |
| Istanbul, Turkey, 34098 | |
Sponsors and Collaborators
Istanbul University-Cerrahpasa
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | April 30, 2019 | ||
| First Posted Date | May 2, 2019 | ||
| Last Update Posted Date | May 6, 2019 | ||
| Actual Study Start Date | August 30, 2016 | ||
| Actual Primary Completion Date | November 30, 2016 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
globe salvage [ Time Frame: 2-5 years ] globe salvage rate after superselective intra-arterial chemotherapy treatment for retinoblastoma
|
||
| Original Primary Outcome Measures | Same as current | ||
| Change History | |||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey | ||
| Official Title | Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey | ||
| Brief 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 for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated. |
||
| Detailed Description | Not Provided | ||
| Study Type | Observational | ||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Non-Probability Sample | ||
| 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 | ||
| Condition | Retinoblastoma | ||
| Intervention | Drug: intra-arterial administration of melphalan | ||
| Study Groups/Cohorts |
|
||
| 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. | ||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Actual Enrollment |
30 | ||
| Original Actual Enrollment | Same as current | ||
| Actual Study Completion Date | November 30, 2016 | ||
| Actual Primary Completion Date | November 30, 2016 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||
| Sex/Gender |
|
||
| Ages | 5 Months to 7 Years (Child) | ||
| Accepts Healthy Volunteers | Not Provided | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | Turkey | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT03935074 | ||
| Other Study ID Numbers | 10136532 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement |
|
||
| Responsible Party | Bilge Batu Oto, Istanbul University-Cerrahpasa | ||
| Study Sponsor | Istanbul University-Cerrahpasa | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | Istanbul University-Cerrahpasa | ||
| Verification Date | May 2019 | ||
