Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib

NCT ID: NCT02185560

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 453 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-27
• Study Completion Date: 2025-11-30

Brief Summary

This is a non-interventional, multi center post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with Sorafenib within a certain period. The investigator should have made the choice of treatment (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this study.

The enrollment period is of 9 months. The observation period for each patient starts when the therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no longer possible (e.g. lost to follow-up); this will be considered the standard observation period. Those patients, to whom a total of 24 month follow up is possible, information on effectiveness including treatment duration and survival status of the patient and of keratoacanthoma and/or squamous cell cancer development will be collected.

Conditions

Thyroid Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

BAY43-9006

NEXAVAR treatment group

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

Patients treated by Physician with Nexavar under approved local prescriptions

Interventions

Sorafenib (Nexavar, BAY43-9006)

Patients treated by Physician with Nexavar under approved local prescriptions

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)

Exclusion Criteria

• Patients who have already received NEXAVAR treatment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, , Japan

Countries

Japan

Related Links

http://clinicaltrials.bayer.com/

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Other Identifiers

NEXAVAR-TC-01

Identifier Type: OTHER

Identifier Source: secondary_id

17391

Identifier Type: -

Identifier Source: org_study_id