Cognitive ImpairmentNCT02665325
Cognitive Functions During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
An observational study of Cognitive Impairment, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
Trial summary
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）. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- TSH-suppressive therapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Newly diagnosed differentiated thyroid carcinoma.
- Undergo 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.
Who cannot join
- Current or past disorder/disease of the central nervous system or medical condition impacting cognitive functioning.
- Head trauma history with prolonged loss of consciousness.
- Epilepsy, dementia, or learning disability.
- Current or past psychotic-spectrum disorder or current major affective disorder.
- Current substance abuse/dependence.
- Daily tobacco and alcohol use.
Show all 13Show fewer
- Whole brain irradiation or surgery.
- Prior cancer diagnosis or chemotherapy treatment.
- Active autoimmune disorder.
- Insulin-dependent diabetes.
- Uncontrolled allergic condition or asthma.
- Chronic use of oral steroid medication.
- Hormone therapy (estrogen, progestin compounds).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shan Jin
Hohhot, Inner Mongolia, 010050
Shan Jin, PhD, +86-15849338280, jinshangood@163.com
Yun-Tian Yang, PhD, +86-15849338737, yangyuntian@sina.com
About this study
Official title: Cognitive Functions and Mood During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
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.
Read the detailed description
- 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.
- Conditions
- Cognitive Impairment
- Being tested
- TSH-suppressive therapy
- Keywords
- TSH-suppressive therapy, cognitive function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSH-suppressive therapyDrug
Also called Thyroidectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TSH-suppressive therapy | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment assessed with the Mini-Mental State Examination (MMSE)
Measured: 2 years
Cognitive impairment assessed with the Clock Drawing Test (CDT)
Measured: 2 years
Cognitive impairment assessed with the Digit Symbol test (DST)
Measured: 2 years
Cognitive impairment assessed with the Wechsler Memory Scale (WMS)
Measured: 2 years
Cognitive impairment assessed with the Aphasia Battery of Chinese （ABC）
Measured: 2 years
Mood assessed with the patient health questionnaire -9 (PHQ-9)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
- Investigators
- Shan Jin, PhD, Study director, The Affiliated Hospital of Inner Mongolia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665325
- Sponsor's protocol ID
- AHInnerMongolia-Thyroid-01
- Status last verified
- Jul 2023
- First submitted
- 17 Jan 2016
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22278420Biondi 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.
PubMed 20151821Davis 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.
PubMed 19248795Bauer 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.
PubMed 19435829Puighermanal 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.
PubMed 23108544Wekking 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.
PubMed 16322379
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functions and Mood During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT02665325
- Acronym / sponsor ID
- AHInnerMongolia-Thyroid-01
- Conditions
- Cognitive Impairment
- Keywords
- TSH-suppressive therapy, cognitive function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Jan 2016
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TSHsuppressive therapy group | – | Drug: TSH-suppressive therapyTSH-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Newly diagnosed differentiated thyroid carcinoma.
- Undergo 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.
Key exclusion criteria (13 listed)
- Current or past disorder/disease of the central nervous system or medical condition impacting cognitive functioning.
- Head trauma history with prolonged loss of consciousness.
- Epilepsy, dementia, or learning disability.
- Current or past psychotic-spectrum disorder or current major affective disorder.
- Current substance abuse/dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSH-suppressive therapyAlso: ThyroidectomyThyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months. | Drug | TSHsuppressive therapy group |
Primary outcome
Cognitive impairment assessed with the Mini-Mental State Examination (MMSE)
Time frame: 2 years
Cognitive impairment assessed with the Clock Drawing Test (CDT)
Time frame: 2 years
Cognitive impairment assessed with the Digit Symbol test (DST)
Time frame: 2 years
Cognitive impairment assessed with the Wechsler Memory Scale (WMS)
Time frame: 2 years
Cognitive impairment assessed with the Aphasia Battery of Chinese （ABC）
Time frame: 2 years
Mood assessed with the patient health questionnaire -9 (PHQ-9)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 22278420Fiore 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.
- Background: PubMed 20151821Biondi 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.
- Background: PubMed 19248795Davis 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.
- Background: PubMed 19435829Bauer 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.
- Background: PubMed 23108544Puighermanal 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.
- Results publication: PubMed 16322379Wekking 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Jin, PhD study director
The Affiliated Hospital of Inner Mongolia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan Jin, PhD (+86-15849338280, jinshangood@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment assessed with the Mini-Mental State Examination (MMSE) (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665325, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.