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NCT05667948 Clinical Trial

Molecular Analysis and Treatment Options of Thymic Malignancies

Thymic Carcinoma Clinical Trial

Official title:
Molecular Landscape Analysis and Treatment Options for Thymic Epithelial Tumors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05667948
Other study ID # THORACIC002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2026

Study information
Verified date December 2023
Source Shanghai Chest Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thymic malignancies are the most common tumors of the anterior mediastinum, though surgery and radiation often effectively treat thymic carcinomas, a minority continue to progress and eventually lead to death. Therefore, there is an unmet need for more effective therapies for thymic malignancies. Considering the role of molecular alterations has yet to be defined in the treatment of thymoma and thymic malignancies, there is an urgent recognition that molecular alterations in the thymic malignancies are important to predict response and survival for novel targeted therapies. In summary, identification of genetic alterations in thymic malignancies is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with thymic malignancies to further the characterization of molecular alterations and develop (novel) treatments based on the detection.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically proven diagnosis of thymic malignancies - 18 years of age or older - Ability to understand and the willingness to sign a written informed consent document

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Chemotherapy
different treatments based on the molecular analysis

Locations
Country Name City State
China Xiaomin Niu Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) Collect detailed clinical information on patients with thymic malignancies via the electronic medical records 20 years
Primary Disease control rate (DCR) Collect detailed clinical information on patients with thymic malignancies via the electronic medical records 20 years
Primary Progression-free survival (PFS) Collect detailed clinical information on patients with thymic malignancies via the electronic medical records 20 years
Secondary Overall survival (OS) Collect detailed clinical information on patients with thymic malignancies via the electronic medical records 20 years
See also
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Active, not recruiting NCT01025089 - Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma Phase 2