Breast Neoplasms Clinical Trial
Official title:
Hypothyroidism After Postoperative Radiation Therapy in Patients With Breast Cancer:a Prospective Clinical Study
NCT number | NCT04528225 |
Other study ID # | NCC2444 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 15, 2017 |
Est. completion date | February 24, 2020 |
Verified date | August 2020 |
Source | Chinese Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is to prospectively investigate the incidence of hypothyroidism after postoperative radiotherapy and identify risk factors for development of hypothyroidism. Patients with breast cancer treated with surgery followed by radiotherapy is enrolled. Thyroid function was assessed at baseline and different times after radiotherapy. The radiation technique, thyroid dose parameters and hypothyroidism are prospective evaluated, and the dose-effect relationship is analyzed.
Status | Completed |
Enrollment | 729 |
Est. completion date | February 24, 2020 |
Est. primary completion date | February 24, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: Breast cancer patients at first diagnosis, patients who are treated with radiotherapy after breast conserving surgery or modified radical mastectomy, no medical history of hyperthyroidism, hypothyroidism or thyroiditis, have never taken thyroxine, no thyroid surgery. Exclusion Criteria: Absence or ectopic thyroid gland, previous radiotherapy of the neck, diseases of thalamus or pituitary, previous radiotherapy of thalamus or pituitary |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related hypothyroidism as assessed by CTCAE v4.0 | The subclinical and biochemical hypothyroidism are regularly assessed with the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4). | up to 2 years |
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