NCT04162691

Brief Summary

The purpose of this study is to understand how genetics play a role in thymoma. Intratumoral heterogeneity is among the greatest challenges in precision cancer therapy. However, developments in high-throughput single-cell RNA sequencing (scRNA-seq) may now provide the statistical power to dissect the diverse cellular populations of tumors. This study aims to find out how it affects genetic and protein expression in patients with malignant thymoma, compared to Benign thymoma, at a single-cell level using a flow cytometry and RNA-sequencing protocol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 6, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

June 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

November 6, 2019

Last Update Submit

January 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determination of cell population from thymoma

    The genes expression and the cell population

    through study completion, an average of 1 year

Study Arms (2)

Malignant thymoma

Diagnostic Test: Tissue

Benign thymoma

Diagnostic Test: Tissue

Interventions

TissueDIAGNOSTIC_TEST

Four 4-5 mm tissues of the thymoma

Benign thymomaMalignant thymoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the clinic for investigation of a suspected thymoma condition

You may qualify if:

  • Patients diagnosed with thymoma
  • Ability to provide written consent and comply with the protocol
  • At least 18 years of age

You may not qualify if:

  • Patients undergoing thymoma treatment
  • Patients with previous malignancy
  • Known HIV positive status.
  • Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

An Zhao

Hangzhou, 310022, China

RECRUITING

MeSH Terms

Conditions

Thymoma

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Central Study Contacts

An ZHAO, MD, PHD

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 14, 2019

Study Start

June 6, 2020

Primary Completion

June 1, 2021

Study Completion

December 31, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers

Locations