Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT01783535
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, untreated intraocular retinoblastoma. Participants previously diagnosed with unilateral retinoblastoma treated surgically, with focal therapy or needing chemotherapy who develop asynchronous involvement of the contralateral eye, or patients with unilateral retinoblastoma treated only with enucleation or focal therapy who develop asynchronous involvement of the contralateral eye, will be eligible for study.
* ECOG Performance Score must be ≤ 2 within two weeks prior to registration.
* Participants must have an adequate liver function, as defined by bilirubin ≤ to 3X upper limit of normal (ULN), and SGOT and SGPT ≤ to 3X ULN.
* Participants must have adequate renal function as defined by serum creatinine ≤ to 3X ULN for age.
* Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects. Legal guardians will be given a signed copy of the consent form.
Exclusion Criteria:
* Previously treated participants.
* Presence of metastatic disease or gross (residual) orbital involvement
* Participants must not have an invasive infection at time of protocol entry.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01783535
Study Brief:
Protocol Section:
NCT01783535