RB Liquid Biopsy Biorepository

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Brief Title

RB Liquid Biopsy Biorepository

Official Title

Retinoblastoma Patient Clinical Database, Liquid Biopsy and Tissue Biorepository

Brief Summary

      Retinoblastoma (RB) is a primary eye cancer that forms in the back of the eye of infants and
      toddlers. Traditionally, RB is diagnosed without a biopsy; tumor can only be studied once an
      eye has been surgically removed.

      Given this limitation, we use aqueous humor (AH), the clear fluid in the front of the eye to
      detect specific markers, or information, that comes from the tumor itself.
    

Detailed Description

      Retinoblastoma (RB) is a primary intraocular malignancy that forms in the retina of infants
      and toddlers. Traditionally, RB is diagnosed without tissue as direct tumor biopsy is
      prohibited due to risk of extraocular spread; tissue can only be obtained once an eye has
      been surgically removed.

      Given this limitation, there are no eye-specific molecular biomarkers in current clinical
      practice for RB. The lack of in vivo molecular data without removing the eye limits our
      ability to prognosticate clinical outcomes and develop personalized treatment plans. It also
      limits our understanding of intratumoral dynamics throughout therapy.

      The aqueous humor (AH) is a high-yield source of tumor-derived nucleic acid that can be
      utilized as a liquid biopsy in eyes with retinoblastoma. Detection of biomarkers from the AH
      may be used to prognosticate the likelihood of eye salvage and in the future may facilitate
      targeted, patient-centered therapies based on molecular biomarkers.

      OBJECTIVES:

        1. Systematically and prospectively record accurate and complete data regarding the
           clinical presentation, treatment, and outcomes of patients diagnosed with RB.

        2. Collect, bank, preserve, and analyze biomaterials including AH, blood and saliva from
           patients with RB.

        3. Correlate phenotypic data with genotypic findings from human biomaterials in
           retinoblastoma patients to identify clinically relevant biomarkers
    


Study Type

Observational [Patient Registry]


Primary Outcome

Correlation of Ocular Salvage (eye saved) with biomarkers

Secondary Outcome

 Correlation of High-Risk Histopathologic Features with presence of biomarkers

Condition

Retinoblastoma



Publications

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

Recruitment Information



Estimated Enrollment

800

Start Date

January 1, 2017

Completion Date

December 31, 2025

Primary Completion Date

December 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  All patients, age 0 days to 18 years, with a diagnosis unilateral or bilateral
             retinoblastoma (RB) seen at CHLA.

        Exclusion Criteria:

          -  Patients referred for second opinions only and not treated at CHLA for any reason.
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Jesse L Berry, MD, 323-361-4510, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04959097

Organization ID

CHLA-RB-liquid-biopsy


Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital Los Angeles


Study Sponsor

Jesse L Berry, MD, Principal Investigator, Children's Hospital Los Angeles


Verification Date

July 2021