ThymomaNCT04162691
Single Cell Sequencing Analysis of Thymoma
An observational study of Thymoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thymoma
- What is being tested?
- Tissue
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to the clinic for investigation of a suspected thymoma condition
Who may be able to join
- Patients diagnosed with thymoma
- Ability to provide written consent and comply with the protocol
- At least 18 years of age
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
An Zhao
Hangzhou, 310022
An Zhao, Dr, +8618258863556, zhaoan@zjcc.org.cn
An Zhao, PHD
About this study
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.
- Conditions
- Thymoma
- Being tested
- Tissue
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissueDiagnostic test
Four 4-5 mm tissues of the thymoma
| Study group | Role | What they receive |
|---|---|---|
| Malignant thymoma | Not described Receives: Diagnostic Test: Tissue | |
| Benign thymoma | Not described Receives: Diagnostic Test: Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of cell population from thymoma
The genes expression and the cell population
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start6 Jun 2020
- Primary completion1 Jun 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHAO An, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162691
- Sponsor's protocol ID
- SCS-001
- Status last verified
- Jan 2023
- First submitted
- 6 Nov 2019
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Cell Sequencing Analysis of Thymoma
- ClinicalTrials.gov ID
- NCT04162691
- Acronym / sponsor ID
- SCS-001
- Conditions
- Thymoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant thymoma | – | Diagnostic Test: Tissue |
| Benign thymoma | – | Diagnostic Test: Tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the clinic for investigation of a suspected thymoma condition
Key inclusion criteria (3 listed)
- Patients diagnosed with thymoma
- Ability to provide written consent and comply with the protocol
- At least 18 years of age
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TissueFour 4-5 mm tissues of the thymoma | Diagnostic test | Benign thymoma, Malignant thymoma |
Primary outcome
Determination of cell population from thymoma
Time frame: through study completion, an average of 1 year
The genes expression and the cell population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers
Related trials for Thymoma
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Active, not recruitingPhase 1
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
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RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
Thymic Epithelial Tumor, Recurrent Thymoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thymoma, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact An ZHAO, MD, PHD (8688122413, zhaoan@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of cell population from thymoma (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.