Clinical trial · Interventional
Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation
A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Irradiation; Adverse Effect | — | UNRESOLVED | — |
| Irradiation Hypothyroidism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biological sample | Biological | — | UNRESOLVED |
| supraclavicular irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- with supraclavicular irradiation
- description
- Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period
- interventionNames
- Biological: biological sample
- Radiation: supraclavicular irradiation
- type
- ACTIVE_COMPARATOR
- label
- without supraclavicular irradiation
- description
- Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period
- interventionNames
- Biological: biological sample
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women older than 18 * Non metastatic breast cancer, histologically proved, whatever T and N stages and receptors status. * Breast cancer treated by surgery (either initial treatment then biotherapies and/or neoadjuvant chemotherapy, either secondarily after biotherapies and/or neoadjuvant chemotherapy, either without chemotherapy and/or biotherapies) * Breast cancer requiring an adjuvant radiotherapy * Treatment by radiotherapy made in participating centers * Information of patient and signature of the informed consent. Exclusion Criteria: * Pre-existent dysthyroidism revealed before radiotherapy or at inclusion checkup (THS lower or superior to the standard of the laboratory, whatever the rate of free T4) * History of thyroid surgery * Bilateral breast cancer * History of cervical and/or supra-clavicular radiotherapy * Lack of social security insurance * Subjects deprived of free behavior or under administrative control
References
Publications (0)
Data not yet available