A Real-World Study of Second-line Therapies Among Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC) Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Adult RAI-R DTC patients from the rEHR database in China.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: RAI-R DTC Cohort

Trial outcomes

Primary outcomes

1

Proportion of Patients Receiving Second-line Systematic Therapy

Second-line systematic therapy includes lenvatinib, anlotinib, sorafenib, donafenib, and D+T.

Time frame
Up to 6 years
2

Duration of Second-line Systematic Therapy

Duration of therapy with lenvatinib, anlotinib, sorafenib, donafenib, and D+T.

Time frame
Up to 6 years

Secondary outcomes

1

Proportion of Patients by Demographics and Clinical Characteristics

Demographics and clinical characteristics include sex/gender, Tumor Node Metastasis (TNM) stage, BRAF V600E and co-mutation status, presence of distant metastasis, and MKI tolerability-related comorbidities.

Time frame
Baseline
2

Age

Time frame
Baseline
3

Proportion of Patients Who had Surgery Prior to Second-line Systematic Therapy

Time frame
Baseline
4

Proportion of Patients Who Received 131I Radioiodine Therapy Prior to Second-line Systematic Therapy

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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