Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma

NCT04451304 | Unknown

• 1 other identifier: CAAE 28598120.5.0000.5505
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinoblastoma; Retinoblastoma Bilateral; Chemotherapy Effect

Keywords

Retinoblastoma

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory autonomic reflexes incidence

  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 Outcomes (1)

• Clinical background and autonomic reflexes occurence

  from the admission of the patient in the operating room until the end of the procedure.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal of the patient or guardian to participate in the research project

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• Mariana F Lima, MD, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana F Lima, MD, PhD

CONTACT

+551150809236; marifonteslima@yahoo.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: June 15, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

BR (1)