Studying Health Outcomes After Treatment in Patients With Retinoblastoma

Learn more about:
Related Clinical Trial
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma RB Liquid Biopsy Biorepository Topotecan and Melphalan for Retinoblastoma Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure – Preliminary Study Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma. Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study Topotecan Episcleral Plaque for Treatment of Retinoblastoma G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment PCI Imaging System in Pediatric Ophthalmology Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients Conservative Treatments of Retinoblastoma Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma Photoscreening for Retinoblastoma RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients Studying Health Outcomes After Treatment in Patients With Retinoblastoma Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma Intra-arterial Chemotherapy for Retinoblastoma Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma Phase I Trial of Periocular Topotecan in Retinoblastoma Episcleral Topotecan for Treatment of Group D Retinoblastoma Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma? CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation Alternating Systemic Chemotherapy and Intra-Arterial Melphalan (IAM) Chemotherapy in Children With Intra-Ocular Retinoblastoma Chemotherapy in Treating Patients With Retinoblastoma New Strategies to Detect Cancers in Carriers of Mutations in RB1 Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma Carboplatin Plus Vincristine in Treating Children With Retinoblastoma Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma Quality of Life in Children Cured of Retinoblastoma Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009) Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma SPT Screening in Irradiated Hereditary Retinoblastoma Survivors Attention to Retinoblastoma Diagnosed in the Trauma Setting Carboplatin Periocular Injection for Retinoblastoma Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala Research on the Environment and Children’s Health: Retinoblastoma Intravitreal Injections of Melphalan for Retinoblastoma Efficacy Study of Lucentis in the Treatment of Retinoblastoma Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life Retinoblastoma Biomarker Study Cancer Biology of Retinoblastoma Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma Intra-arterial Chemotherapy for Children With Retinoblastoma Molecular Analysis of Retinoblastoma

Brief Title

Studying Health Outcomes After Treatment in Patients With Retinoblastoma

Official Title

Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)

Brief Summary

      This trial studies health outcomes after treatment in patients with retinoblastoma. Gathering
      health information over time from patients and family members through vision assessments,
      samples of tissue and saliva, and questionnaires may help doctors learn more about what
      causes retinoblastoma, identify long-term health outcomes for patients with retinoblastoma,
      and find out which therapies may be the best for treating retinoblastoma
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. Define acute toxicity, subsequent malignant neoplasm (SMN) risk and visual outcomes in
      retinoblastoma (RB) survivors and compare patient centered psychosocial and neurocognitive
      and physical outcomes in survivors with normative data and sibling controls.

      II. Create the first Clinically-Annotated Patient Tissues to Analyze Gene INteractions to
      assess biologic correlates of disease and facilitate future research: The RIVERBOAT-CAPTAIN
      biorepository, including germline deoxyribonucleic acid (DNA) and tumor tissue from patients,
      with detailed patient, disease and treatment-related information.

      III. Using the RIVERBOAT-CAPTAIN clinically-annotated biorepository, determine the interplay
      between specific RB1 mutation type and the role of additional modifier genes in determining
      those tumor phenotypes that drive treatment decisions.

      OUTLINE: Patients are assigned to 1 of 2 cohorts.

      RETROSPECTIVE COHORT: Patients treated between 2008-2018 undergo collection of saliva samples
      at >= 6 months after treatment, and undergo vision assessment at >= 6 months after treatment
      and again 1 year later if necessary. Previously collected tissue samples at the time of
      surgery are also obtained. Patients also complete questionnaires at >= 6 months after
      treatment and again 2 years later.

      PROSPECTIVE COHORT: Patients treated between 2018-2023 undergo collection of saliva samples
      at the time of enrollment and at 6 months after treatment. Patients also undergo vision
      assessment at the time of enrollment, at 6 months, and 18 months after completion of
      treatment. Patients also complete questionnaires at 6 months and again 2 years later, as well
      as undergo collection of tissue samples at the time of surgery. Immediate family members with
      history of RB or RB1 gene mutation also undergo collection saliva samples.
    


Study Type

Observational


Primary Outcome

Incidence of acute toxicity


Condition

Retinoblastoma

Intervention

Biospecimen collection

Study Arms / Comparison Groups

 Retrospective(biospecimens, vision assessment, questionnaires)
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

900

Start Date

January 24, 2019

Completion Date

January 2026

Primary Completion Date

January 2025

Eligibility Criteria

        -  Unilateral or bilateral intraocular retinoblastoma

          -  Diagnosis between the ages of 0 - 17.99 years

          -  Diagnosis on or after January 1, 2008

          -  No exclusions based on primary or secondary treatment modalities

          -  Retrospective group patients must be ≥ 6 months post end of treatment at study entry

               -  For those already at this timepoint, they are now eligible

               -  For those in treatment, or otherwise not yet at this timepoint, they are eligible
                  once at they are ≥ 6 months post end of treatment

               -  Prospective group patients must not have begun treatment

          -  Patients with diminished capacity will not be enrolled.

          -  Language: Patients must be able to communicate in English, French, or Spanish

          -  Sibling Cohort: One sibling, not affected by retinoblastoma will be enrolled,
             preference for the sibling closest in age to the RB patient.

          -  Regulatory Requirements: All patients and/or their parents or legal guardians must
             sign a written informed consent. All institutional, FDA, and NCI requirements for
             human studies must be met.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Debra Friedman, MD, 800-811-8480, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03932786

Organization ID

VICC PED 1878

Secondary IDs

NCI-2019-00635

Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Debra Friedman, MD, Principal Investigator, Vanderbilt Medical Center


Verification Date

April 2021