Multimodal Assesment of Acute Cardiac Toxicity Induced by... | NCT04896242

Studies
Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients

NCT04896242

Sponsor

Pontificia Universidad Catolica de Chile

Status

Completed

Last Update Posted

Apr 4, 2024Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Radiotherapy; Complications
Cardiotoxicity
Cancer
Lung Cancer
Breast Cancer
Esophageal Cancer

Interventions

Not provided

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2020Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

May 9, 2021

First Submission Date that Met QC Criteria

May 17, 2021

First Posted Date

May 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate and compare the changes by two modalities: Imaging by Strain by Speckle Tracking and Magnetic Resonance versus soluble markers of cardiac dysfunction as early predictors of cardio-toxicity in cancer patients receiving low or high doses of radiotherapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global Longitudinal Strain (Left Ventricle)	>5 Absolute drop or 12% Relative reduction from baseline	Baseline, 1 and 12 weeks after Treatment

Secondary Outcomes

Measure	Description	Time Frame
Cardiac Magnetic Resonance Cinema Imaging	Cinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance	Baseline, 1 and 12 weeks after treatment
Cardiac Magnetic Resonance Anatomical Image

Other Outcomes

Measure	Description	Time Frame
High-sensitivity Cardiac Troponin-T	Troponin rises >99%th percentile of the upper reference limit	Baseline, 1 and 12 weeks after treatment
N-Terminal pro-Brain Natriuretic Peptide	N-Terminal pro-Brain Natriuretic Peptide, rises >99%th percentile of the upper reference limit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18 year-old patients
With histologically confirmed thoracic cancer (breast, esophagus or lung)
Recommendation of thoracic radiotherapy (RT) with curative intent
With or without chemotherapy
All patients must be able to read and understand Spanish
All patients must sign informed consent form.

Exclusion Criteria:

Patients with no medical records,
Pregnant
Previously diagnosed with severe left ventricular dysfunction or a cardiac insufficiency
Patients with metastatic disease and indication of palliative RT
Patients with significant comorbidities associated to a <5 year life expectancy.
Patients previously treated with thoracic RT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with cancer of the thoracic area (lung, breast, esophagus or other thoracic locations) that will receive curative radiotherapy to the thoracic region at Pontificia Universidad Católica de Chile.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomas Merino Lara	Pontificia Universidad Catolica de Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pontificia Universidad Catolica de Chile		Santiago	Santiago Metropolitan		Chile

Condition Browse Module

MeSH Terms

ID	Term
D066126	Cardiotoxicity
D009369	Neoplasms
D008175	Lung Neoplasms
D001943	Breast Neoplasms
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided