NSCLCNCT04950907
Uniportal Tubeless VATS for the Evaluation of Biopsy for Second-generation Sequencing in Patients With Advanced NSCLC
A study testing vats and CT-guided fine needle biopsy in people with NSCLC and Biopsy Technique, run by Jianxing He.
Trial summary
The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, Biopsy Technique, VATS
- What is being tested?
- vats and CT-guided fine needle biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to 26 Jun 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent is obtained
- Assessed by more than 2 surgeons, patients whose lesions can be achieved by tubeless single-port thoracoscopic surgical biopsy
Who cannot join
- History of other malignant tumors.
- The general condition is not suitable for puncture, bronchoscopy, or surgery (such as cardiopulmonary dysfunction, high risk of bleeding, allergy to anesthetics, confusion, inability to exercise, etc.)
- History of lung surgery, tuberculosis and coal mine work experience, etc. may cause severe chest adhesions; other situations that conflict with the biopsy process
About this study
Official title: A Randomized Controlled Study of Single Port Tubeless VATS for the Evaluation of Qualified Rate of Biopsy for Second-generation Tibial Specimens in Patients With Advanced NSCLC
The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.
- Conditions
- NSCLC, Biopsy Technique, VATS, CT Guided Puncture Biopsy, NGS
- Being tested
- vats, CT-guided fine needle biopsy
- Keywords
- NSCLC, biopsy technique, VATS, CT guided puncture biopsy, NGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vatsDiagnostic test
Use uniportal tubeless VATS to obtain the biopsy
CT-guided fine needle biopsyDiagnostic test
Use CT-guided fine needle to obtain the biopsy
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Uniportal VATS biopsy Receives: Diagnostic Test: vats |
| control | Active comparator | CT-guided fine needle biopsy Receives: Diagnostic Test: CT-guided fine needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualified Rate of Biopsy for Second-generation Tibial Specimens
Different biopsy methods (single-port tubeless VATS biopsy vs CT-guided fine-needle aspiration biopsy) are used to evaluate the qualification rate of samples obtained for NGS testing
Measured: up to 2 years
Secondary outcomes (13)
Progression Free Survival
Progression Free Survival of patients under different biopsy methods
Measured: up to 2 years
Overall Survival
Overall Survival of patients under different biopsy methods
Measured: up to 2 years
Tumor Content Size
Tumor Content of patients under different biopsy methods
Measured: up to 2 years
Gene Mutation Rate
Gene Mutation Rate of patients under different biopsy methods
Measured: up to 2 years
Drug sensitive mutation detection rate
Drug sensitive mutation detection rate of patients under different biopsy methods
Measured: up to 2 years
Detection of PD-L1 expression
Detection of PD-L1 expression of patients under different biopsy methods
Measured: up to 2 years
TMB detection situation
TMB detection situation of patients under different biopsy methods
Measured: up to 2 years
Correlation between tumor cell content and detection rate of sensitive mutations
Measured: up to 2 years
Perioperative complications
Measured: up to 2 years
Postoperative patient experience score
Measured: up to 2 years
Usage rate of targeted drug
Measured: up to 2 years
Success rate of enrollment
Measured: up to 2 years
Postoperative MRD detection
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion26 Jun 2023 (estimated)
- Study completion26 Jun 2024 (estimated)
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianxing He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950907
- Sponsor's protocol ID
- 20210301
- Status last verified
- Jul 2021
- First submitted
- 14 Jun 2021
- Last updated
- 13 Jul 2021
- 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Single Port Tubeless VATS for the Evaluation of Qualified Rate of Biopsy for Second-generation Tibial Specimens in Patients With Advanced NSCLC
- ClinicalTrials.gov ID
- NCT04950907
- Acronym / sponsor ID
- 20210301
- Conditions
- NSCLC, Biopsy Technique, VATS, CT Guided Puncture Biopsy, NGS
- Keywords
- NSCLC, biopsy technique, VATS, CT guided puncture biopsy, NGS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Jianxing HeUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 26 Jun 2023 (estimated)
- Study completion
- 26 Jun 2024 (estimated)
- First posted
- 6 Jul 2021 (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 study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Diagnostic Test: vatsUniportal VATS biopsy |
| control | Active comparator | Diagnostic Test: CT-guided fine needle biopsyCT-guided fine needle biopsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent is obtained
- Assessed by more than 2 surgeons, patients whose lesions can be achieved by tubeless single-port thoracoscopic surgical biopsy
Key exclusion criteria (3 listed)
- History of other malignant tumors.
- The general condition is not suitable for puncture, bronchoscopy, or surgery (such as cardiopulmonary dysfunction, high risk of bleeding, allergy to anesthetics, confusion, inability to exercise, etc.)
- History of lung surgery, tuberculosis and coal mine work experience, etc. may cause severe chest adhesions; other situations that conflict with the biopsy process
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 |
|---|---|---|
| vatsUse uniportal tubeless VATS to obtain the biopsy | Diagnostic test | treatment |
| CT-guided fine needle biopsyUse CT-guided fine needle to obtain the biopsy | Diagnostic test | control |
Primary outcome
Qualified Rate of Biopsy for Second-generation Tibial Specimens
Time frame: up to 2 years
Different biopsy methods (single-port tubeless VATS biopsy vs CT-guided fine-needle aspiration biopsy) are used to evaluate the qualification rate of samples obtained for NGS testing
13 secondary outcomes
Progression Free Survival
Time frame: up to 2 years
Overall Survival
Time frame: up to 2 years
Tumor Content Size
Time frame: up to 2 years
Gene Mutation Rate
Time frame: up to 2 years
Drug sensitive mutation detection rate
Time frame: up to 2 years
Detection of PD-L1 expression
Time frame: up to 2 years
TMB detection situation
Time frame: up to 2 years
Correlation between tumor cell content and detection rate of sensitive mutations
Time frame: up to 2 years
Perioperative complications
Time frame: up to 2 years
Postoperative patient experience score
Time frame: up to 2 years
Usage rate of targeted drug
Time frame: up to 2 years
Success rate of enrollment
Time frame: up to 2 years
Postoperative MRD detection
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
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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 vats and CT-guided fine needle biopsy in people with NSCLC and Biopsy Technique, run by Jianxing He.
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 3 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 Jul 2021. 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?
Results are not available in the source record.
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?
Qualified Rate of Biopsy for Second-generation Tibial Specimens (time frame: up to 2 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 13 Jul 2021.