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Active surveillance and TSH inhibition therapy for low-risk Papillary Thyroid Microcarcinoma

Active surveillance and TSH inhibition therapy for low-risk Papillary Thyroid Microcarcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098603
Enrollment
Unknown
Registered
2025-03-11
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-risk papillary thyroid microcarcinoma

Interventions

Group A (TSH suppression treatment group):According to the patients condition and TSH level, 90 patients were given appropriate dose of thyroid hormone replacement therapy to maintain TSH at a low lev
Group B (control group) :90 cases only received routine follow-up observation without TSH suppression therapy.

Sponsors

Beijing Tongren Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Family history of thyroid cancer and radiation exposure during adolescence. 2. Pathologically confirmed papillary thyroid carcinoma with a diameter less than 10mm; 3. No distant metastasis, no external thyroid invasion, no lymph node metastasis, no pathological high-risk subtypes, no tracheal or recurrent laryngeal nerve invasion and other clinical high-risk factors; 4. Aged between 18 and 75, male or non-pregnant or non-lactating female; 5. Normal function of major organs and stable vital signs; 6. Complete clinical data of patients; 7. Able to comply with the study visit schedule, and understand and comply with all test protocol requirements; 8. Able and willing to sign informed consent.

Exclusion criteria

Exclusion criteria: Subjects will not be admitted to the study if they meet any of the following criteria: 1. The psychological test questionnaire indicated that patients with anxiety type, sensitive type or high anxiety value; 2. Tumor growth exceeding 3mm or tumor diameter greater than 10mm was found during follow-up; 3. Patients with severe cardiac, liver and renal insufficiency; 4. Patients with grade I or above coronary heart disease, arrhythmias (including prolonged QTc interval > 450 ms in men and > 470 ms in women) and cardiac insufficiency; 5. Osteoporosis, hypocalcemia; 6. Patients with other malignant tumors; 7. Allergic patients have been confirmed to the drugs used in this study; 8. Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 9. Participate in other drug clinical trials as a subject, and the last trial drug administration is less than 4 weeks after the first administration of the drug in this study; 10. Patients with other concomitant diseases that, in the judgment of the investigator, endanger the patient's safety or affect the patient's completion of the study; 11. Plan to receive any other antitumor therapy during this trial.

Design outcomes

Primary

MeasureTime frame
Thyroid Stimulating Hormone;Tumor size;

Secondary

MeasureTime frame
Location of the tumor;Tumor echogenicity;Relationship between tumor and capsule and relationship with nerve;

Countries

China

Contacts

Public ContactChen Xiaohong

Beijing Tongren Hospital Affiliated to Capital Medical University

trchxh@163.com+86 139 1107 1002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026