Status:
WITHDRAWN
Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out whether people who have had thyroid cancer develop resistance to treatment with thyroid hormones after having received high doses of thyroid drugs for many yea...
Eligibility Criteria
Inclusion
- Age 18 or older
- Due to a diagnosis of thyroid cancer, patient underwent a total thyroidectomy based on pathology.
- No evidence of active disease based on routine surveillance testing showing no suspicious findings on neck ultrasound and low thyroglobulin levels (≤1.0 ng/ml) with negative thyroglobulin antibodies within one year of study enrollment. For the study patients, this response can be evaluated after five years of TSH suppression. For control subjects, this response can be evaluated after two years of surveillance.
- Two groups:
- 8 patients with a history of thyroid hormone suppression (TSH\<0.5 mU/L) for at least 5 years
- 8 patients with no history of TSH suppression
- Normal TSH level based on the laboratory reference range for at least 6 months at the time of study enrollment.
- Blood pressure range of \>90/60 and \<180/100. Patients may be included in the study if blood pressure has been treated with medication and normalized.
Exclusion
- Patient reported history of symptomatic heart disease including unstable angina or NYHA stage III or IV heart failure.
- Patient reported history of one of the following cardiac arrhythmias: atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, ventricular fibrillation, or ventricular tachycardia.
- Patient reported history of uncontrolled hypotension (\<90/60) or hypertension (\>180/100).
- History of renal dysfunction with creatinine more than 1.5 times the upper limit of normal based on recent laboratory testing
- Known hypersensitivity to the drug
- Pregnant or breast feeding
- Prior history of seizures or brain damage
- Patients on chronic therapy with levodopa
- Patients on therapeutic doses of acetylsalicylic acid (2 - 3.6 gm/day)
- Patients with conditions that result in disruption of the hypothalamic-pituitary axis (i.e. hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma).
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04868045
Start Date
April 27 2021
End Date
February 15 2023
Last Update
February 21 2023
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