A Real-World Study of Second-line Therapies Among Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC) Patients
Real-World Evidence of Second-line Systematic Therapy With BRAF V600E Mutation-guided Dabrafenib + Trametinib or Mutation-agnostic Multi-targeted Tyrosine Kinase Inhibitors (MKIs) in Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC)
1 other identifier
observational
200
0 countries
N/A
Brief Summary
This study aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib (D+T) and MKIs, among Chinese adult patients with RAI-R DTC. This is a non-interventional study using secondary data derived from a real-world Electronic Health Record (rEHR) database in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2026
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedStudy Start
First participant enrolled
October 8, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
Study Completion
Last participant's last visit for all outcomes
October 31, 2026
August 18, 2026
August 1, 2026
23 days
August 10, 2026
August 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of Patients Receiving Second-line Systematic Therapy
Second-line systematic therapy includes lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Up to 6 years
Duration of Second-line Systematic Therapy
Duration of therapy with lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Up to 6 years
Secondary Outcomes (7)
Proportion of Patients by Demographics and Clinical Characteristics
Baseline
Age
Baseline
Proportion of Patients Who had Surgery Prior to Second-line Systematic Therapy
Baseline
Proportion of Patients Who Received 131I Radioiodine Therapy Prior to Second-line Systematic Therapy
Baseline
Proportion of Patients by First-line Therapy
Baseline
- +2 more secondary outcomes
Study Arms (1)
RAI-R DTC Cohort
Adult patients diagnosed with RAI-R DTC.
Eligibility Criteria
Adult RAI-R DTC patients from the rEHR database in China.
You may qualify if:
- Patients with a diagnosis of thyroid cancer.
- Patients with a pathological confirmation of differentiated thyroid cancer (DTC).
- Patients who initiated either MKI monotherapy (lenvatinib, sorafenib, anlotinib, donafenib, apatinib, sunitinib, cabozantinib, pralsetinib) or D+T combination therapy between January 1, 2019 and December 31, 2025 (or the data cutoff date).
- Patients with no curative-intent thyroid cancer surgery within 3 months after initiation of systematic therapy.
You may not qualify if:
- Patients participating in a blinded interventional clinical trial, or any open-label observational study involving D+T or MKI, during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2026
First Posted
August 18, 2026
Study Start (Estimated)
October 8, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
August 18, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share