NSCLCNCT03073902
The Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.
An observational study of NSCLC, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 expression in serum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Liquid biopsy
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2017to 10 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pathological histology and/or cytology confirmed non-small lung cancer
Who may be able to join
- Pathological histology and/or cytology confirmed non-small lung cancer;
- Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
Who cannot join
- Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
- Patients with a history of autoimmune disease;
- Patients with participating in other clinical trials at the same time;
- Other cases that researchers believe that patients should not participate in the present trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Research for the Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.
The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 expression in serum and peripheral blood T cell are expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum..The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum.By using variance analysis of repeated measures design information. Thus exploring the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum,guiding clinical practice of immunotherapy.
- Conditions
- NSCLC
- Being tested
- Liquid biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsyDiagnostic test
Liquid biopsy
| Study group | Role | What they receive |
|---|---|---|
| Observed group | The project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum.The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum by using variance analysis of repeated measures design information. Receives: Diagnostic Test: Liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The match rate of PD-L1 protein expression in non-small lung cancer tissue and peripheral blood T cell .
consistency
Measured: up to two years
The match rate of PD-L1 protein expression in non-small lung cancer tissue and serum.
consistency
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start25 Mar 2017
- Primary completion31 Mar 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073902
- Sponsor's protocol ID
- XQonc-006
- Status last verified
- Dec 2018
- First submitted
- 26 Feb 2017
- Last updated
- 28 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research for the Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.
- ClinicalTrials.gov ID
- NCT03073902
- Acronym / sponsor ID
- XQonc-006
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 8 Mar 2017 (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 detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 expression in serum and peripheral blood T cell are expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum..The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum.By using variance analysis of repeated measures design information. Thus exploring the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum,guiding clinical practice of immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed group | – | Diagnostic Test: Liquid biopsyThe project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum.The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum by using variance analysis of repeated measures design information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathological histology and/or cytology confirmed non-small lung cancer
Key inclusion criteria (2 listed)
- Pathological histology and/or cytology confirmed non-small lung cancer;
- Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
Key exclusion criteria (4 listed)
- Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
- Patients with a history of autoimmune disease;
- Patients with participating in other clinical trials at the same time;
- Other cases that researchers believe that patients should not participate in the present trial.
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 |
|---|---|---|
| Liquid biopsyLiquid biopsy | Diagnostic test | Observed group |
Primary outcome
The match rate of PD-L1 protein expression in non-small lung cancer tissue and peripheral blood T cell .
Time frame: up to two years
consistency
The match rate of PD-L1 protein expression in non-small lung cancer tissue and serum.
Time frame: up to two years
consistency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NSCLC, run by Xinqiao Hospital of Chongqing 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 2 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: finished, as of the sponsor's last update on 28 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The match rate of PD-L1 protein expression in non-small lung cancer tissue and peripheral blood T cell . (time frame: up to two years). The study lists 2 primary outcomes in all. 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 28 Dec 2018.