Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood (SALTO-SNA)
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Purpose
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 | Intervention |
|---|---|
|
Cancer Sequels Complications Autonomic Nervous System |
Other: Autonomic nervous system activity records |
| Study Type: | Observational |
| Study Design: | 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 |
- Autonomic nervous system activity [ Time Frame: 15 years after the end of the cancer treatment ] [ Designated as safety issue: No ]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).
- Doses of radiotherapy [ Time Frame: 15 years after the end of the cancer treatment ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 508 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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| 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 | |
| Principal Investigator: | Claire BERGER, MD | CHU de Saint-Etienne |
| Study Director: | Hugues PATURAL, MD PhD | CHU de Saint-Etienne |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT01574196 History of Changes |
| Other Study ID Numbers: | 1108162, 2011-A01357-34 |
| Study First Received: | April 6, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority |
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 |
ClinicalTrials.gov processed this record on May 16, 2013