NCT01574196|Completed
Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood
SALTO-SNA
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SALTO-SNA
Sponsor study identifier
Secondary identifiers
OTHER · AFSSAPS
observational
83
1 country
4
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2012
Actual (reported)April 10, 2012
Actual (reported)September 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)December 2014
Actual (reported)Autonomic nervous system activity
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).
15 years after the end of the cancer treatment
Doses of radiotherapy
15 years after the end of the cancer treatment
Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
CHU de Grenoble
Grenoble, 38000, France
IHOP
Lyon, 69000, France
CHU de Saint-Etienne
Saint-Etienne, 42000, France
Claire BERGER, MD
CHU de Saint-Etienne
Hugues PATURAL, MD PhD
CHU de Saint-Etienne
83 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2012
First Posted
April 10, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Impact on the Nutritional State and the Quality of Life
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Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
March 31, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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