NSCLCRadImm01NCT02890849
Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome
A study testing Liquid biopsy in people with NSCLC, run by Xinqiao Hospital of Chongqing.
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 mRNA in plasma… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC
- What is being tested?
- Liquid biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathological histology and/or cytology confirmed malignant tumor;
- 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.
About this study
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 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with 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 biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| a prospective, open, self-controlled phase I clinical study | Experimental | The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.by using variance analysis of repeated measures design information. Receives: Other: 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 cancer tissue and PD-L1 mRNA expression in pExo.
Measured: up to one and a half years
Secondary outcomes (1)
The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue.
Measured: up to one and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2019
- Study completionAug 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02890849
- Sponsor's protocol ID
- XQonc-004
- Acronym
- RadImm01
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2016
- Last updated
- 23 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome
- ClinicalTrials.gov ID
- NCT02890849
- Acronym / sponsor ID
- RadImm01 / XQonc-004
- Conditions
- NSCLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a prospective, open, self-controlled phase I clinical study | Experimental | Other: Liquid biopsyThe project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.by using variance analysis of repeated measures design information. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pathological histology and/or cytology confirmed malignant tumor;
- 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 biopsy | Other | a prospective, open, self-controlled phase I clinical study |
Primary outcome
The match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in pExo.
Time frame: up to one and a half years
1 secondary outcome
The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue.
Time frame: up to one and a half years
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 23 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid biopsy in people with NSCLC, run by Xinqiao Hospital of Chongqing.
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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 cancer tissue and PD-L1 mRNA expression in pExo. (time frame: up to one and a half years). 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 23 Feb 2024.