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Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood (SALTO-SNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574196
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Cancer Sequels Complications Autonomic Nervous System Other: Autonomic nervous system activity records

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood. Ancillary Study of the "Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France" Study
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Autonomic nervous system activity [ Time Frame: 15 years after the end of the cancer treatment ]
    The autonomic status will be classified in sympatho-vagal equilibrium as "normal", "altered" or "severely abnormal" according to the values obtained for some temporal indices (SDNN, SDaNN, RMSSD etc. ..) and frequencies (Ptot, HF, LF , VLF, ratio LF / HF) compared to validated standards for the age (mean +/- standard deviation).


Secondary Outcome Measures :
  1. Doses of radiotherapy [ Time Frame: 15 years after the end of the cancer treatment ]
    Regarding radiotherapy, the doses of different vital organs of the body (151 anatomic sites) will be estimated from the radiotherapy technical records with the help of the Dos-EG software proposed by the INSERM team of F De Vathaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a prospective cohort study in non-leukemia cancer survivors diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France, who were younger than 15 years at the time of diagnosis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574196


Locations
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France
CHU de Clermont-Ferrand
Clermont-ferrand, France, 63000
CHU de Grenoble
Grenoble, France, 38000
IHOP
Lyon, France, 69000
CHU de Saint-Etienne
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Claire BERGER, MD CHU de Saint-Etienne
Study Director: Hugues PATURAL, MD PhD CHU de Saint-Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01574196    
Other Study ID Numbers: 1108162
2011-A01357-34 ( Other Identifier: AFSSAPS )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Childhood cancer
Cancer
Sequels
Complications
Chemotherapy
 Radiotherapy
Surgery
Autonomic nervous system
Parasympathetic Nervous System
Sympathetic Nervous System