Clinical trial NCT01574196: Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Sequels
Complications
Autonomic Nervous System
Keywords: Childhood cancer
Cancer
Sequels
Complications
Chemotherapy
Radiotherapy
Surgery
Autonomic nervous system
Parasympathetic Nervous System
Sympathetic Nervous System
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Autonomic nervous system activity
timeFrame: 15 years after the end of the cancer treatment
Secondary outcomes:
measure: Doses of radiotherapy
timeFrame: 15 years after the end of the cancer treatment
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: IHOP
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Claire BERGER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Saint-Etienne
name: Hugues PATURAL, MD PhD
role: STUDY_DIRECTOR
References: