Clinical trial NCT05028270: Treatment of Intraocular Retinoblastoma
Official title: Clinical Study of Superselective Ophthalmic Artery Interventional Chemotherapy for Intraocular Retinoblastoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinoblastoma
Keywords: Retinoblastoma;Intravenous chemotherapy;Eye protection rate
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 1600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children dignosed retinoblastoma

Brief summary: This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma

Detailed description: Retinoblastoma is the most common intraocular malignant tumor in childhood, with an incidence of about 1/15,000-20,000, accounting for 4% of all childhood cancers. All patients with bilateral reticuloblastoma and approximately 10%-15% of children with unilateral disease have germline mutations that can be passed on to their offspring.In developed countries, the survival rate is close to 98%. However, due to the limitations of health care in low-income countries, this proportion is much lower, about 40%. Before the 1990s, retinoblastoma was mainly treated with enucleation and external beam radiation therapy (EBRT). However, these methods are associated with many complications, including vision loss and serious side effects. At present, the first-line conservative treatment of retinoblastoma has changed from EBRT and enucleation to Intravenous chemotherapy (IVC) or intra-arterial chemotherapy (IAC), and it has been consolidated through focal treatment. There are two different surgical procedures for intra-arterial chemotherapy, namely balloon technique and microcatheter technique. Investigators observe their effects through a retrospective case-control study.

Eligibility criteria: Inclusion Criteria:

1. 1 year old \<age ≤ 18 years old;
2. After biopsy, histopathology and immunohistochemistry tests refer to the COG recommended neuroblastoma diagnostic criteria, pathological classification (INPC), and international neuroblastoma staging (INSS)
3. Patients who were diagnosed with RB for the first time or received chemotherapy in our hospital for the first time after diagnosis
4. ECOG scale (ECOG-PS) ≤ 2;

Exclusion Criteria:

1. No antibiotics and no gastrointestinal surgery within 3 months.
2. Patients with autoimmune diseases;
3. Patients with immunodeficiency;
4. Patients who have been treated for relapsed/refractory diseases; relapsed NB is the appearance of new lesions at the primary site or other sites 4 weeks after the multidisciplinary comprehensive treatment reaches CR. Refractory NB is defined as induced by 2 to 4 courses of treatment The post-effect evaluation is progression disease (PD) during chemotherapy;
5. Multiple organ failure;
6. Uncontrolled infection and diarrhea

Primary outcomes:
measure: Overall success rate
timeFrame: 1 year
measure: Second tumor rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Min Shi
role: STUDY_CHAIR
References: