Observing the treatment of Graves' disease

The Observation Study of Graves' Disease Cohort

This study looks at how people with Graves' disease are treated and followed up to better understand their symptoms and immune responses.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05043233 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with Graves' disease hyperthyroidism, aiming to establish standard diagnosis and treatment procedures. Conducted at Ruijin Hospital, it involves a follow-up of patients to gather data that will support future research protocols. The study will assess the clinical manifestations and immune factors involved in the disease, particularly the role of CD4+ T cells. By documenting patient experiences and outcomes, the study seeks to enhance understanding and management of Graves' disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with diagnosed Graves' disease hyperthyroidism and specific clinical symptoms.

Not a fit: Patients who have previously undergone radioactive iodine treatment or surgery for Graves' disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and treatment protocols for patients with Graves' disease.

How similar studies have performed: While there are few observational studies on Graves' disease in China, the approach of this study is relatively novel and aims to fill a gap in existing research.

Eligibility criteria

Inclusion Criteria:

Patients aged 18-70 years old with normal BMI (18-25), who are diagnosed with Graves' disease hyperthyroidism in accordance with the 2016 American Thyroid Association's guidance at the first diagnosis, or patients who relapse after more than one year of medication withdrawal.

1. High metabolic symptoms such as fear of heat, sweating, and palpitations;
2. Diffuse enlargement of thyroid gland, B-ultrasound of thyroid gland indicates diffuse thyroid disease and increased blood flow of thyroid;
3. Serological detection of TSH levels decreased and FT3 and/or FT4 increased; meanwhile, TRAb was positive (TRAb\>1.75 IU/L);
4. Accompanied by thyroid infiltrating ocular signs or pretibial mucous edema.

Exclusion Criteria:

1. Patients with Graves' disease who have previously undergone radioactive iodine 131 or surgery;
2. Blood routine WBC\<3×109/L, neutrophils\<1.5×109/L, or accompanied by other malignant blood diseases;
3. Patients with other serious heart, liver, lung, kidney disease or malignant tumors;
4. In the past six months, there is a history of using immunosuppressants or other autoimmune diseases such as systemic lupus erythematosus, Sjogren's syndrome, etc.;
5. Pregnant and lactating women; Allergies to the drugs used in the treatment plan; and any situation (medical, psychological, social, or geographical factors) that may endanger the safety of the patient or prevent the patient from successfully participating in the study.

Where this trial is running

Shanghai, Shanghai

• Ruijin hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Weiqing Wang, MD,PhD — Shanghai Jiao Tong University School of Medicine
• Study coordinator: Yulin Zhou, MD,PhD

Conditions Patient Acceptance of Health Care