Clinical efficacy and safety of BRAF/MEK inhibitors for anaplastic thyroid cancer; An observational study of ATC Research Consortium of Japan.

JRCT ID: jRCT1031240365

Registered date:03/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anaplastic thyroid cancer
• Date of first enrollment: 01/05/2024
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: 12-month survival rate in patients treated with BRAF inhibitors

Secondary Outcome

1. Prevalence of BRAF gene mutations in ATC cases in Japan
2. Evaluation of prognostic factors in all cases
3. Efficacy and safety of BRAF inhibitors in cases treated with BRAF inhibitors
4. Evaluation of surgery in cases treated with BRAF inhibitors

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

1. Patients who have been histologically diagnosed with anaplastic thyroid cancer
2. Patients aged 20 years or older

Exclude criteria

1. Patients with active multiple primary cancers (lesions equivalent to carcinoma in situ or intramucosal cancer that are deemed curable by local treatment will not be included in active concurrent cancers)
2. Patients who are deemed ineligible for this study by the researchers
3. Patients who refuse to provide data for this study

Related Information

• Primary Sponsor: Suganuma Nobuyasu
• Secondary Sponsor: Japan Association of Endocrine Surgery