Molecular Analysis and Treatment Options of Thymic Malignancies

NCT05667948 | Recruiting

• 1 other identifier: THORACIC002
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thymic Epithelial Tumor; Thymic Carcinoma; Thymic Cancer

Keywords

thymic malignancy; thymoma; chemotherapy; targeted therapy; immunotherapy; molecular landscape

Outcome Measures

Primary Outcomes (3)

• Objective response rate (ORR)

  Collect detailed clinical information on patients with thymic malignancies via the electronic medical records

  20 years

• Disease control rate (DCR)

  Collect detailed clinical information on patients with thymic malignancies via the electronic medical records

  20 years

• Progression-free survival (PFS)

  Collect detailed clinical information on patients with thymic malignancies via the electronic medical records

  20 years

Secondary Outcomes (1)

• Overall survival (OS)

  20 years

Interventions

Chemotherapy DRUG

different treatments based on the molecular analysis

Also known as: targeted therapy, immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with thymic malignancies are with the standard treatment and/or are enrolled in the clinical trials.

You may qualify if:

• Histologically proven diagnosis of thymic malignancies
• years of age or older
• Ability to understand and the willingness to sign a written informed consent document

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Xiaomin Niu

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The specimens are stored in the refrigerator at -20°C or -80°C as specified in the clinical trial protocol. Test specimens and backup specimens should be kept in separate refrigerators to prevent malfunction of one of the refrigerators. Centrifugation time, specimen collection and specimen storage time should be carried out in strict accordance with the requirements of the clinical trial protocol.

MeSH Terms

Conditions

Thymic epithelial tumor; Thymoma; Thymus Neoplasms

Interventions

Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 29, 2022
• Study Start: January 1, 2016
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)