Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become the malignant neoplasm of fastest growing incidence rate. More than 90% thyroid carcinoma is thyroid differentiated carcinoma(DTC). Postoperative oral L-thyroxine suppressing thyroid stimulating hormone (TSH) treatment is the standard therapy in DTC patients. While TSH-suppressive therapy with L-thyroxine can cause subclinical hyperthyroidism in treatment of patients with thyroid differentiated carcinoma. The impact of this therapy on cognitive functions and mood have not been systematically studied. The investigators infer the subclinical hyperthyroidism caused by TSH-suppressive therapy may impact cognitive function and mood disorders in DTC patients. The aim of this study is to explore the possible mechanism of cognitive function impairment in the course of TSH-suppressive therapy by rat model of total thyroidectomy + TSH-suppressive therapy and clinical trials. The result of this study may provide clinical and experimental basis for the side effects risk result form TSH-suppressive therapy in DTC patients.
Object:
Patients aged 18-65 years; newly diagnosed differentiated thyroid carcinoma and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months.
Clinical information, examination data and neuropsychological assessments:
Information is obtained from medical record abstraction. Serum T3, T4, FT3, FT4, TSH, TG-ab, TPO-ab, TG levels and neuropsychological assessments are examined after TSH-suppressive therapy 6 /12 months. Cognitive complaints were assessed with the Mini-Mental State Examination (MMSE), Clock Drawing Test (CDT), Digit Symbol test (DST), Wechsler Memory Scale (WMS), Aphasia Battery of Chinese (ABC) and patient health questionnaire-9 (PHQ-9).
Healthy volunteers (normal T3, T4, FT3, FT4, TSH, TG-ab, TPO-ab, TG) are recruited to match the patients with age, gender, education level, etc.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSHsuppressive therapy group | TSH-suppressive therapy group: newly diagnosed differentiated thyroid carcinoma and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months. |
| |
| Negative control group | Healthy volunteers (normal T3,T4,FT3,FT4,TSH, TG-ab,TPO-ab,TG) are recruited to match the patients with age, gender, education level, ect. | ||
| Positive control group | Newly diagnosed nodular goiter and undergone thyroidectomy according to the China thyroid association guidelines for the management of thyroid nodule and thyroid cnacer; followed by L-T4 replacement therapy 6/12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSH-suppressive therapy | Drug | Thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive impairment assessed with the Mini-Mental State Examination (MMSE) | 2 years | |
| Cognitive impairment assessed with the Clock Drawing Test (CDT) | 2 years | |
| Cognitive impairment assessed with the Digit Symbol test (DST) | 2 years | |
| Cognitive impairment assessed with the Wechsler Memory Scale (WMS) | 2 years | |
| Cognitive impairment assessed with the Aphasia Battery of Chinese (ABC) | 2 years | |
| Mood assessed with the patient health questionnaire -9 (PHQ-9) | 2 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients aged 18-65 years; newly diagnosed differentiated thyroid carcinoma and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shan Jin, PhD | Contact | +86-15849338280 | jinshangood@163.com | |
| Yun-Tian Yang, PhD | Contact | +86-15849338737 | yangyuntian@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Shan Jin, PhD | The Affiliated Hospital of Inner Mongolia Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shan Jin | Recruiting | Hohhot | Inner Mongolia | 010050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22278420 | Background | Fiore E, Vitti P. Serum TSH and risk of papillary thyroid cancer in nodular thyroid disease. J Clin Endocrinol Metab. 2012 Apr;97(4):1134-45. doi: 10.1210/jc.2011-2735. Epub 2012 Jan 25. | |
| 20151821 | Background | Biondi B, Cooper DS. Benefits of thyrotropin suppression versus the risks of adverse effects in differentiated thyroid cancer. Thyroid. 2010 Feb;20(2):135-46. doi: 10.1089/thy.2009.0311. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013965 | Thyroidectomy |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 19248795 | Background | Davis PJ, Zhou M, Davis FB, Lansing L, Mousa SA, Lin HY. Mini-review: Cell surface receptor for thyroid hormone and nongenomic regulation of ion fluxes in excitable cells. Physiol Behav. 2010 Feb 9;99(2):237-9. doi: 10.1016/j.physbeh.2009.02.015. Epub 2009 Feb 25. |
| 19435829 | Background | Bauer M, Silverman DH, Schlagenhauf F, London ED, Geist CL, van Herle K, Rasgon N, Martinez D, Miller K, van Herle A, Berman SM, Phelps ME, Whybrow PC. Brain glucose metabolism in hypothyroidism: a positron emission tomography study before and after thyroid hormone replacement therapy. J Clin Endocrinol Metab. 2009 Aug;94(8):2922-9. doi: 10.1210/jc.2008-2235. Epub 2009 May 12. |
| 23108544 | Background | Puighermanal E, Busquets-Garcia A, Maldonado R, Ozaita A. Cellular and intracellular mechanisms involved in the cognitive impairment of cannabinoids. Philos Trans R Soc Lond B Biol Sci. 2012 Dec 5;367(1607):3254-63. doi: 10.1098/rstb.2011.0384. |
| 16322379 | Result | Wekking EM, Appelhof BC, Fliers E, Schene AH, Huyser J, Tijssen JG, Wiersinga WM. Cognitive functioning and well-being in euthyroid patients on thyroxine replacement therapy for primary hypothyroidism. Eur J Endocrinol. 2005 Dec;153(6):747-53. doi: 10.1530/eje.1.02025. |