Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma

June 25, 2020 updated by: Mariana Fontes Lima Neville, Federal University of São Paulo

Cardiorespiratory Autonomic Reflexes During Superselective Ophthalmic Artery Chemotherapy for Retinoblastoma in Children: a Prospective Observational Study.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-062
        • Recruiting
        • Federal University of São Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing cancer treatment for unilateral or bilateral retinoblastoma at the Instituto de Oncologia Pediátrica da Universidade Federal de São Paulo - GRAACC, São Paulo - Brasil.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory autonomic reflexes incidence
Time Frame: from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)
To evaluate the incidence of cardiorespiratory autonomic reflexes during intra-arterial chemotherapy of the ophthalmic artery in a child cancer center.
from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical background and autonomic reflexes occurence
Time Frame: from the admission of the patient in the operating room until the end of the procedure.
To evaluate the association between perioperative characteristics (both baseline and intraoperative characteristics) and the incidence of cardiorespiratory autonomic reflexes
from the admission of the patient in the operating room until the end of the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Mariana F Lima, MD, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Anticipated)

July 15, 2021

Study Completion (Anticipated)

July 15, 2021

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 28598120.5.0000.5505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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