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Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

NCT02824016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-08-31

No results posted yet for this study

Summary

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.

Conditions

  • Irradiation; Adverse Effect
  • Irradiation Hypothyroidism

Interventions

BIOLOGICAL

biological sample

T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

RADIATION

supraclavicular irradiation

Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions

Sponsors & Collaborators

  • Institut Jean-Godinot

    lead OTHER

Principal Investigators

  • Yacine MERROUCHE, MD · Institut Jean-Godinot

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-07-31
Completion
2020-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02824016 on ClinicalTrials.gov