Cancer Clinical Trial
— SALTO-SNAOfficial 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
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-ferrand | |
France | CHU de Grenoble | Grenoble | |
France | IHOP | Lyon | |
France | CHU de Saint-Etienne | Saint-etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Doses of radiotherapy | 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. | 15 years after the end of the cancer treatment | No |
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