Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood

NCT ID: NCT01574196

Last Updated: 2015-03-31

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

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en Oncologie des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne) coordinated by Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at re-examining, in their initial treatment center, all patients (a cohort of 495 patients alive in 2011), diagnosed between 1987 and 1992, and cured of childhood cancer (except leukemia) in the Rhône-Alpes and Auvergne regions.

The rationale for this study is based on the observation that although the survival rate of childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are high and greatly increase the risk of mortality in later years (estimated to be 14% in the literature).

The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor of cardiovascular morbidity to the individual.

Detailed Description

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For this purpose, analysis of the cardiac RR variability is a reliable, non-invasive and reproducible system that could be used in this population as a tool for early detection of cardiovascular dysfunction.

Conditions

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Cancer Sequels Complications Autonomic Nervous System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Young adult survivors of childhood cancer

Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France.

Autonomic nervous system activity records

Intervention Type OTHER

The description of autonomic equilibrium is based on the use of non-invasive tools such as Holter-ECG monitor (24 hours) which is suitable for longitudinal follow up of cohorts of patients. This tool allows the analysis of instantaneous or delayed variability of the heart rate, in the Hertzian frequency domain after extraction and mathematical transformation of a temporal sequence of R-R spaces from the ECG signal.

Interventions

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Autonomic nervous system activity records

The description of autonomic equilibrium is based on the use of non-invasive tools such as Holter-ECG monitor (24 hours) which is suitable for longitudinal follow up of cohorts of patients. This tool allows the analysis of instantaneous or delayed variability of the heart rate, in the Hertzian frequency domain after extraction and mathematical transformation of a temporal sequence of R-R spaces from the ECG signal.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Included in the SALTO study
* Having signed the informed consent form

Exclusion Criteria

* General anesthesia in the two weeks prior to recording
* Known allergy to electrodes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire BERGER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Hugues PATURAL, MD PhD

Role: STUDY_DIRECTOR

CHU de Saint-Etienne

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

IHOP

Lyon, , France

Site Status

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2011-A01357-34

Identifier Type: OTHER

Identifier Source: secondary_id

1108162

Identifier Type: -

Identifier Source: org_study_id

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