biological sample
BiologicalT4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
NCT Number: NCT02824016
Prospective, multicentric, comparative, non randomised, in current care.
Primary objective:
* To evaluate the incidence of hypothyroidism in breast cancer patients treated by radiotherapy including the supra-clavicular area over a period of 5 years (60 months).
Secondary objectives :
* To calculate the dose of irradiation received by thyroid gland during the treatment. * To compare the rate of incidence of hypothyroidism in women who received a supra-clavicular irradiation (group 1)and in those who did not (group 2). * To estimate and compare the rate of incidence of chronic thyroid lesions in the 2 groups. * To look for predictive factors of hypothyroidism de novo in group 1 women particularly regarding the dose-volume parameters. * To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.
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Notify Me18 year and older
Female
Interventional
Not applicable
Institut Jean Godinot, Reims, France
Prospective, multicentric, comparative, non randomised, in current care study
2 patient groups, non randomised, according to the necessity or not to perform a supra-clavicular irradiation:
Schedule
Projected inclusion duration of 18 months (duration to possibly adapt in order to obtain the number of required patients)
Intermediate study of the results in 30 months
Duration of follow-up of 60 months
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions
Time frame: Outcome measures will be assessed every 6 months up to 5 years.
Institut Jean-Godinot
Other
A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
Acronym: EPITHERM
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