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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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|
|Study Type :||Observational|
|Actual Enrollment :||83 participants|
|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|
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.
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- Included in the SALTO study
- Having signed the informed consent form
- General anesthesia in the two weeks prior to recording
- Known allergy to electrodes
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
|CHU de Clermont-Ferrand|
|Clermont-ferrand, France, 63000|
|CHU de Grenoble|
|Grenoble, France, 38000|
|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|
|Responsible Party:||Centre Hospitalier Universitaire de Saint Etienne|
|Other Study ID Numbers:||
2011-A01357-34 ( Other Identifier: AFSSAPS )
|First Posted:||April 10, 2012 Key Record Dates|
|Last Update Posted:||March 31, 2015|
|Last Verified:||March 2015|
Autonomic nervous system
Parasympathetic Nervous System
Sympathetic Nervous System