Differentiated Thyroid CarcinomaNCT04916262
Correlation Between TCM Syndrome Factors and TSH Changes of Thyroid Hormone Withdrawal Before Iodine Therapy in Postoperative Patients With Thyroid Cancer
An observational study of Differentiated Thyroid Carcinoma and TCM Syndrome Type, run by Qianfoshan Hospital.
Trial summary
The purpose of this study is to make a dialectical classification of patients who will receive 131I treatment after operation of thyroid cancer from the point of view of dialectics of syndrome elements of traditional Chinese medicine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Differentiated Thyroid Carcinoma, TCM Syndrome Type
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2021to 1 Jan 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thyroid cancer who need 131I therapy after operation
Who may be able to join
- Study time: June 1, 2021, to January 1, 2022;
- Study site: The First Affiliated Hospital of Shandong First Medical University;
- 18-75 years old (including upper and lower limits), male or female;
- Patients with differentiated thyroid carcinoma diagnosed pathologically after total thyroidectomy
- Patients with oral levothyroxine tablets ≥ 4 weeks after operation
- Patients who have stopped taking levothyroxine tablets and whose TSH < 4.2uIU/ml at the time of withdrawal
- Patients who meet the 131I treatment criteria
Who cannot join
- Pregnant or lactating women
- Patients with various mental disorders, unconscious, etc.
- Cases with inaccurate information collection
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to make a dialectical classification of patients who will receive 131I treatment after operation of thyroid cancer from the point of view of dialectics of syndrome elements of traditional Chinese medicine. By observing the changes of TSH among patients with different syndrome types, investigators can better understand the reasons for the differences in TSH changes among patients. Thus, it provides a basis for putting forward the scheme of stopping taking levothyroxine before iodine treatment, improving the quality of life of patients after radical thyroidectomy, and providing reference for individualized guidance of the timing of radioactive iodine therapy for patients after DTC.
Read the detailed description
Thyroid cancer is a common thyroid tumor. In the past few decades, the incidence of thyroid cancer in most parts of the world has increased steadily year by year. At present, the best treatment for differentiated thyroid cancer at home and abroad is surgery + radioactive iodine + thyroid hormone replacement inhibition.131I therapy, as an important adjuvant therapy for patients with DTC, can effectively remove the residual thyroid tissue and unresectable local and distant metastatic lesions during the operation.
It is considered that the level of TSH and the time of thyroid hormone withdrawal are important factors affecting the efficacy of radioiodine therapy, and there is a close relationship between the two factors. Clinically, investigators also observed that TSH changes were different in patients who were about to receive iodine treatment after DTC during the withdrawal of thyroxine. In some patients, TSH levels rise rapidly in a short period of time, while others rise slowly. For patients with rapid increase of TSH (sometimes even more than 100uIU/ml), it may promote tumor growth, recurrence and recessive metastasis. Patients with slow rise of TSH may need to constantly review thyroid function until reaching the standard, which brings inconvenience to patients, and withdrawal of drugs for too long will affect patients' physical, psychological and living conditions, resulting in patient discomfort.
In this study, the dialectical classification of TCM syndrome factors was carried out in the patients before radioiodine therapy after DTC. After collecting the patients who met the inclusion and exclusion criteria, they were divided into two groups according to TSH ≤ 30uIU/mL and TSH > 30uIU/mL on the 14th day. The TCM syndrome elements and other clinical information of each group were collected respectively. Investigators will observe the changes of TSH in patients with different types of TCM syndrome factors, and gain a deeper understanding of the reasons for the differences in TSH changes. Investigators hope to provide a basis for putting forward a plan to stop thyroxine before iodine therapy, to improve the quality of life of postoperative patients with thyroid cancer, and to provide a reference for individualized guidance of the timing of radioactive iodine therapy for patients after DTC.
- Keywords
- Differentiated Thyroid Carcinoma, TCM syndrome type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TSH < 30uIU/mL group | Clinical information was collected from patients with TSH < 30UIU /mL on the 14th day of thyroxine withdrawal before 131I treatment，including TCM syndrome elements, general information ,medical history and biochemical examination during hospitalization. | |
| TSH ≥ 30uIU/mL group | Clinical information was collected from patients with TSH ≥ 30UIU /mL on the 14th day of thyroxine withdrawal before 131I treatment，including TCM syndrome elements, general information ,medical history and biochemical examination during hospitalization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure 1
The TCM syndrome types of patients participating in this study were evaluated by TCM syndrome factor scale, and the diagnosis was established when the total weight of the scale was more than 20
Measured: The data will be collected, analyzed and calculated in about 3 days.
Primary Outcome Measure 2
Correlation analysis was used to analyze the correlation between TCM syndrome types and the time needed for thyrotropin ≥ 30uIU/ml during the treatment of thyroid hormone withdrawal.
Measured: The data will be collected, analyzed and calculated in about 3 days.
Secondary outcomes (8)
Secondary Outcome Measure 1
To observe the TSH≥30uIU/mL rate after Withdrawal of Suppressive Thyroxine Therapy 2 weeks in Preparation for Radioactive Iodine Administration to Patients with differentiated thyroid cancer.
Measured: 2 weeks.
Secondary Outcome Measure 2
Correlation analysis was used to analyze the effect of age (in years) on the level of serum TSH after thyroxine withdrawal treatment.
Measured: 2 weeks.
Secondary Outcome Measure 3
The effect of gender on serum TSH level after thyroxine withdrawal treatment was analyzed by correlation analysis.
Measured: 2 weeks.
Secondary Outcome Measure 4
Height and weight measurement instrument (HW-900Y) was used to measure height (in meters). Correlation analysis was used to analyze the effect of height on serum TSH level after thyroxine withdrawal treatment.
Measured: 2 weeks.
Secondary Outcome Measure 5
The height and weight meter (HW-900Y) was used to measure the body weight (in kilograms), and the correlation analysis was used to analyze the effect of weight on the level of serum TSH after thyroxine withdrawal treatment.
Measured: 2 weeks.
Secondary Outcome Measure 6
weight and height will be combined to report BMI in kg/m^2.Correlation analysis was used to analyze the effect of BMI on serum TSH level after thyroxine withdrawal therapy.
Measured: 2 weeks.
Secondary Outcome Measure 7
Total cholesterol detection kit (COD-PAP) was used to measure serum cholesterol (in mmol/l). Correlation analysis was used to analyze the effect of serum cholesterol on serum TSH level after thyroxine withdrawal treatment.
Measured: 2 weeks.
Secondary Outcome Measure 8
Serum triglyceride (mmol/l) was detected by triglyceride determination kit (GPO-PAP). The effect of serum triglyceride on serum TSH level after thyroxine withdrawal treatment was analyzed by SPSSstatistics20.0.
Measured: 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start20 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Differentiated Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Lin Liao, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916262
- Sponsor's protocol ID
- LJB-02
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou Y, Yang Y, Zhou T, Li B, Wang Z. Adiponectin and Thyroid Cancer: Insight into the Association between Adiponectin and Obesity. Aging Dis. 2021 Apr 1;12(2):597-613. doi: 10.14336/AD.2020.0919. eCollection 2021 Apr.
PubMed 33815885Stewart LA, Kuo JH. Advancements in the treatment of differentiated thyroid cancer. Ther Adv Endocrinol Metab. 2021 Mar 17;12:20420188211000251. doi: 10.1177/20420188211000251. eCollection 2021.
PubMed 33796254Borges de Souza P, McCabe CJ. Radioiodine treatment: an historical and future perspective. Endocr Relat Cancer. 2021 Sep 3;28(10):T121-T124. doi: 10.1530/ERC-21-0037. No abstract available.
PubMed 33690155Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between TCM Syndrome Factors and TSH Changes of Thyroid Hormone Withdrawal Before Iodine Therapy in Postoperative Patients With Thyroid Cancer
- ClinicalTrials.gov ID
- NCT04916262
- Acronym / sponsor ID
- LJB-02
- Keywords
- Differentiated Thyroid Carcinoma, TCM syndrome type
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 7 Jun 2021 (actual)
- 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.
The purpose of this study is to make a dialectical classification of patients who will receive 131I treatment after operation of thyroid cancer from the point of view of dialectics of syndrome elements of traditional Chinese medicine. By observing the changes of TSH among patients with different syndrome types, investigators can better understand the reasons for the differences in TSH changes among patients. Thus, it provides a basis for putting forward the scheme of stopping taking levothyroxine before iodine treatment, improving the quality of life of patients after radical thyroidectomy, and providing reference for individualized guidance of the timing of radioactive iodine therapy for patients after DTC.
Detailed description
Thyroid cancer is a common thyroid tumor. In the past few decades, the incidence of thyroid cancer in most parts of the world has increased steadily year by year. At present, the best treatment for differentiated thyroid cancer at home and abroad is surgery + radioactive iodine + thyroid hormone replacement inhibition.131I therapy, as an important adjuvant therapy for patients with DTC, can effectively remove the residual thyroid tissue and unresectable local and distant metastatic lesions during the operation.
It is considered that the level of TSH and the time of thyroid hormone withdrawal are important factors affecting the efficacy of radioiodine therapy, and there is a close relationship between the two factors. Clinically, investigators also observed that TSH changes were different in patients who were about to receive iodine treatment after DTC during the withdrawal of thyroxine. In some patients, TSH levels rise rapidly in a short period of time, while others rise slowly. For patients with rapid increase of TSH (sometimes even more than 100uIU/ml), it may promote tumor growth, recurrence and recessive metastasis. Patients with slow rise of TSH may need to constantly review thyroid function until reaching the standard, which brings inconvenience to patients, and withdrawal of drugs for too long will affect patients' physical, psychological and living conditions, resulting in patient discomfort.
In this study, the dialectical classification of TCM syndrome factors was carried out in the patients before radioiodine therapy after DTC. After collecting the patients who met the inclusion and exclusion criteria, they were divided into two groups according to TSH ≤ 30uIU/mL and TSH > 30uIU/mL on the 14th day. The TCM syndrome elements and other clinical information of each group were collected respectively. Investigators will observe the changes of TSH in patients with different types of TCM syndrome factors, and gain a deeper understanding of the reasons for the differences in TSH changes. Investigators hope to provide a basis for putting forward a plan to stop thyroxine before iodine therapy, to improve the quality of life of postoperative patients with thyroid cancer, and to provide a reference for individualized guidance of the timing of radioactive iodine therapy for patients after DTC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TSH < 30uIU/mL group | – | –Clinical information was collected from patients with TSH < 30UIU /mL on the 14th day of thyroxine withdrawal before 131I treatment，including TCM syndrome elements, general information ,medical history and biochemical examination during hospitalization. |
| TSH ≥ 30uIU/mL group | – | –Clinical information was collected from patients with TSH ≥ 30UIU /mL on the 14th day of thyroxine withdrawal before 131I treatment，including TCM syndrome elements, general information ,medical history and biochemical examination during hospitalization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid cancer who need 131I therapy after operation
Key inclusion criteria (7 listed)
- Study time: June 1, 2021, to January 1, 2022;
- Study site: The First Affiliated Hospital of Shandong First Medical University;
- 18-75 years old (including upper and lower limits), male or female;
- Patients with differentiated thyroid carcinoma diagnosed pathologically after total thyroidectomy
- Patients with oral levothyroxine tablets ≥ 4 weeks after operation
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Patients with various mental disorders, unconscious, etc.
- Cases with inaccurate information collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome Measure 1
Time frame: The data will be collected, analyzed and calculated in about 3 days.
The TCM syndrome types of patients participating in this study were evaluated by TCM syndrome factor scale, and the diagnosis was established when the total weight of the scale was more than 20
Primary Outcome Measure 2
Time frame: The data will be collected, analyzed and calculated in about 3 days.
Correlation analysis was used to analyze the correlation between TCM syndrome types and the time needed for thyrotropin ≥ 30uIU/ml during the treatment of thyroid hormone withdrawal.
8 secondary outcomes
Secondary Outcome Measure 1
Time frame: 2 weeks.
Secondary Outcome Measure 2
Time frame: 2 weeks.
Secondary Outcome Measure 3
Time frame: 2 weeks.
Secondary Outcome Measure 4
Time frame: 2 weeks.
Secondary Outcome Measure 5
Time frame: 2 weeks.
Secondary Outcome Measure 6
Time frame: 2 weeks.
Secondary Outcome Measure 7
Time frame: 2 weeks.
Secondary Outcome Measure 8
Time frame: 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 33815885Zhou Y, Yang Y, Zhou T, Li B, Wang Z. Adiponectin and Thyroid Cancer: Insight into the Association between Adiponectin and Obesity. Aging Dis. 2021 Apr 1;12(2):597-613. doi: 10.14336/AD.2020.0919. eCollection 2021 Apr.
- Background: PubMed 33796254Stewart LA, Kuo JH. Advancements in the treatment of differentiated thyroid cancer. Ther Adv Endocrinol Metab. 2021 Mar 17;12:20420188211000251. doi: 10.1177/20420188211000251. eCollection 2021.
- Background: PubMed 33690155Borges de Souza P, McCabe CJ. Radioiodine treatment: an historical and future perspective. Endocr Relat Cancer. 2021 Sep 3;28(10):T121-T124. doi: 10.1530/ERC-21-0037. No abstract available.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
Related trials for Differentiated Thyroid Carcinoma
RecruitingPhase 2
Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer
Differentiated Thyroid Carcinoma
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingPhase 2
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
Thyroid Cancer
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Enrolling by invitationPhase 3
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Cancer, Renal Cell Carcinoma (RCC)
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.
Lin Liao, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Carcinoma and TCM Syndrome Type, run by Qianfoshan Hospital.
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 7 inclusion and 3 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Lin Liao, Doctor (18354117713, liaolin@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1 (time frame: The data will be collected, analyzed and calculated in about 3 days.). The study lists 2 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 NCT04916262, which also lists 4 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 16 Jun 2021.