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Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma

Brazil200 participantsStarted 2020-06-15

Plain-language summary

Prospective observational study in patients undergoing intra-arterial ophthalmic artery chemotherapy for the treatment of retinoblastoma. The main objective of the study is to evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to investigate the association between autonomic reflexes and perioperative clinical characteristics.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients diagnosed with retinoblastoma and submitted to intra-arterial chemotherapy during the study period * Informed consent form signed and dated by legal guardian and investigator * Informed assent form signed by the patient if appropriate Exclusion Criteria: * Refusal of the patient or guardian to participate in the research project

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiorespiratory autonomic reflexes incidence

Timeframe: from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)

Trial details

NCT IDNCT04451304

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-15

Contact for this trial

Mariana F Lima, MD, PhD

+551150809236 marifonteslima@yahoo.com.br

View on ClinicalTrials.gov More Retinoblastoma trials