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Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma

NCT ID: NCT04451304

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Retinoblastoma Retinoblastoma Bilateral Chemotherapy Effect

Keywords

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Retinoblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Mariana Fontes Lima Neville

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana F Lima, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mariana F Lima, MD, PhD

Role: CONTACT

Phone: +551150809236

Email: [email protected]

Facility Contacts

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Mariana F Lima, MD

Role: primary

Other Identifiers

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CAAE 28598120.5.0000.5505

Identifier Type: -

Identifier Source: org_study_id