Molecular Analysis and Treatment Options of Thymic Malignancies

Sponsor
Shanghai Chest Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05667948
Collaborator
(none)
500
1
132
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Molecular Landscape Analysis and Treatment Options for Thymic Epithelial Tumors
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [20 years]

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

  2. Disease control rate (DCR) [20 years]

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

  3. Progression-free survival (PFS) [20 years]

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

Secondary Outcome Measures

  1. Overall survival (OS) [20 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiaomin Niu Shanghai Shanghai China 200030

Sponsors and Collaborators

  • Shanghai Chest Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaomin Niu, Principal Investigator, Shanghai Chest Hospital
ClinicalTrials.gov Identifier:
NCT05667948
Other Study ID Numbers:
  • THORACIC002
First Posted:
Dec 29, 2022
Last Update Posted:
Dec 29, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiaomin Niu, Principal Investigator, Shanghai Chest Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2022