NCT07179341

Brief Summary

Background Thymic carcinoma (TC) is a rare and aggressive mediastinal malignancy with poor prognosis. Our study aimed to develop a nomogram to predict overall survival (OS) of TC patients. Method A total of 156 patients confirmed TC between 1996 and 2023 were selected from our database. They were divided into training cohort, validation cohort one and validation cohort two. A nomogram was constructed based on the risk factors affecting prognosis using a Cox proportional hazards regression model. The discrimination and calibration of the nomogram were evaluated by C-index, AUC and curve of calibration. The three cohorts were divided into low-risk and high-risk subgroups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 4, 2025

Last Update Submit

September 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival (OS) is the length of time a patient lives after a diagnosis or the start of treatment for a disease, such as cancer

    From date of accepting surgery until the date of final documented or date of death from any cause, whichever came first, assessed up to 325 months

Study Arms (3)

Training cohort

ACTIVE COMPARATOR

156 patients diagnosed with TC accepting surgery

Procedure: Thymectomy for thymic carcinoma

Validation cohort one

PLACEBO COMPARATOR

80 patients range from June 1, 1996, to January 1, 2015 accepting surgery

Procedure: Thymectomy for thymic carcinoma

Validation cohort two

PLACEBO COMPARATOR

76 patients range from January 2, 2015, to July 1, 2023 accepting surgery

Procedure: Thymectomy for thymic carcinoma

Interventions

Thymectomy for thymic cancer

Training cohortValidation cohort oneValidation cohort two

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnosis of TC in patients should be confirmed through endoscopic tumor biopsy or surgery to obtain tumor tissue for pathological confirmation under light microscope, and even further confirmed through immunohistochemical staining.
  • Patients should accept surgery and obtain complete postoperative pathological reports in order to assess Masaoka-Koga staging.
  • Patients who accepted surgery should be followed up at least six months or reached the endpoint event.

You may not qualify if:

  • The patient had two types of primary tumors concurrently including TC.
  • The tumor in the thymus was not primary but metastatic, having originated from a different primary site.
  • The patient did not obtain a complete pathological report after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Thymoma

Interventions

Thymectomy

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 17, 2025

Study Start

July 9, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations