- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162691
Single Cell Sequencing Analysis of Thymoma
January 12, 2023 updated by: ZHAO An, Zhejiang Cancer Hospital
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: An ZHAO, MD, PHD
- Phone Number: 8688122413
- Email: zhaoan@zjcc.org.cn
Study Locations
-
-
-
Hangzhou, China, 310022
- Recruiting
- An Zhao
-
Contact:
- An Zhao, Dr
- Phone Number: +8618258863556
- Email: zhaoan@zjcc.org.cn
-
Principal Investigator:
- An Zhao, PHD
-
Principal Investigator:
- Zongping Wang, MD
-
Principal Investigator:
- Yipeng Xu, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred to the clinic for investigation of a suspected thymoma condition
Description
Inclusion Criteria:
- Patients diagnosed with thymoma
- Ability to provide written consent and comply with the protocol
- At least 18 years of age
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Malignant thymoma
|
Four 4-5 mm tissues of the thymoma
|
|
Benign thymoma
|
Four 4-5 mm tissues of the thymoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of cell population from thymoma
Time Frame: through study completion, an average of 1 year
|
The genes expression and the cell population
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2020
Primary Completion (Actual)
June 1, 2021
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
November 6, 2019
First Submitted That Met QC Criteria
November 11, 2019
First Posted (Actual)
November 14, 2019
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to make individual participant data (IPD) available to other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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