Lung Squamous Cell CarcinomaNCT05778253
The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC
An observational study of Lung Squamous Cell Carcinoma, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Squamous Cell Carcinoma
- What is being tested?
- WES and ctDNA detection
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 23 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Resectable or potentially resectable stage II-IIIb lung squamous cell carcinoma patients receiving neoadjuvant chemoimmunotherapy
Who may be able to join
- Histopathology or cytology confirmed the lung squamous cell carcinoma
- Age ranging from 18 to 75
- Agree to participate in this study and sign an informed consent form
- Treatment-naive tumor
- According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
- Sufficient tissue/blood samples are available to meet research requirements
- The ECOG PS score is 0-1
Who cannot join
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
- Non-squamous NSCLC
- Unresectable IIIa-IIIb tumor
- Patients with solid organ or blood system transplantation
- Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
- Patients with interstitial lung disease
Show all 9Show fewer
- Patients with acute or chronic infectious disease
- Pregnant and lactating women
- Patients who have undergone other clinical drug trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
Changsha, Hunan, 410011
Yan Hu, M.D., Ph.D., yanhu@csu.edu.cn
About this study
Official title: Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)
The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.
Read the detailed description
This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with lung squamous cell carcinoma receiving neoadjuvant chemoimmunotherapy (ranging 2 to 4 cycles) will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for whole exon sequencing (WES) testing, and personalized detection panel will be customized based on WES testing results. Peripheral blood will be collected 1 day before each cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery, and 3 weeks after surgery for ctDNA testing. In addition, the prediction model of AI-based pathology will be constructed by AI deep learning based on pathological sections of pre-treatment biopsy tissues. All inclued patients will be regularly followed up for at least 5 years.
- Conditions
- Lung Squamous Cell Carcinoma
- Being tested
- WES and ctDNA detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WES and ctDNA detectionDiagnostic test
WES and ctDNA detection
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy | Not described Receives: Diagnostic Test: WES and ctDNA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic completet response (pCR) rate
pCR rate is defined as the percentage of participants having an absence of residual tumor cells in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: Up to 1 year
ctDNA resolution
ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathologic complete response (pCR)
Measured: Up to 2 years
Development of computer algorithm to identify pCR features
Development of computer algorithm to identify pCR features
Measured: From retrospective data collection to algorithm development (6 month)
Validation of computer algorithm to identify pCR features
Validation of computer algorithm to identify pCR features
Measured: From prospective data collection to algorithm validation (6 months)
Secondary outcomes (8)
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and resected lymph nodes following completion of neoadjuvant therapy.
Measured: Up to 1 year
Objective response rate(ORR)
The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery.
Measured: Up to 1 year
Adverse events (AEs)
Number of participants experiencing AEs will be recorded. An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 5 years
Perioperative complications rate
Number of participants experiencing perioperative complications will be recorded.
Measured: Up to 3 years
Health-related Quality of Life
Health-related Quality of Life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0, the EORTC Quality of Life Questionnaire in Lung Cancer (EORTC QLQ-LC13), and the European Quality of Life 5 Dimensions (EQ-5D) questionnaire.
Measured: Up to 5 years
Perioperative pain evaluation
Perioperative pain evaluation assessed by a numeric rating scale (NRS)
Measured: Up to 3 years
Disease free survival (DFS)
From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.
Measured: Up to 5 years
Overall survival (OS)
From the date of participated in study to the date of death.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start23 Mar 2023 (estimated)
- Primary completion23 Sep 2028 (estimated)
- Study completion23 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai OrigiMed Co., Ltd.
- Responsible party
- Principal investigator, Liu Wenliang, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778253
- Sponsor's protocol ID
- LYF2022198
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 21 Mar 2023
- 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 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)
- ClinicalTrials.gov ID
- NCT05778253
- Acronym / sponsor ID
- LYF2022198
- Conditions
- Lung Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Shanghai OrigiMed Co., Ltd.
- Study start
- 23 Mar 2023 (estimated)
- Primary completion
- 23 Sep 2028 (estimated)
- Study completion
- 23 Sep 2029 (estimated)
- First posted
- 21 Mar 2023 (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 goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.
Detailed description
This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with lung squamous cell carcinoma receiving neoadjuvant chemoimmunotherapy (ranging 2 to 4 cycles) will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for whole exon sequencing (WES) testing, and personalized detection panel will be customized based on WES testing results. Peripheral blood will be collected 1 day before each cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery, and 3 weeks after surgery for ctDNA testing. In addition, the prediction model of AI-based pathology will be constructed by AI deep learning based on pathological sections of pre-treatment biopsy tissues. All inclued patients will be regularly followed up for at least 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy | – | Diagnostic Test: WES and ctDNA detection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Resectable or potentially resectable stage II-IIIb lung squamous cell carcinoma patients receiving neoadjuvant chemoimmunotherapy
Key inclusion criteria (7 listed)
- Histopathology or cytology confirmed the lung squamous cell carcinoma
- Age ranging from 18 to 75
- Agree to participate in this study and sign an informed consent form
- Treatment-naive tumor
- According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
Key exclusion criteria (9 listed)
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
- Non-squamous NSCLC
- Unresectable IIIa-IIIb tumor
- Patients with solid organ or blood system transplantation
- Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
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 |
|---|---|---|
| WES and ctDNA detectionWES and ctDNA detection | Diagnostic test | Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy |
Primary outcome
Pathologic completet response (pCR) rate
Time frame: Up to 1 year
pCR rate is defined as the percentage of participants having an absence of residual tumor cells in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
ctDNA resolution
Time frame: Up to 2 years
ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathologic complete response (pCR)
Development of computer algorithm to identify pCR features
Time frame: From retrospective data collection to algorithm development (6 month)
Development of computer algorithm to identify pCR features
Validation of computer algorithm to identify pCR features
Time frame: From prospective data collection to algorithm validation (6 months)
Validation of computer algorithm to identify pCR features
8 secondary outcomes
Major pathological response (MPR) rate
Time frame: Up to 1 year
Objective response rate(ORR)
Time frame: Up to 1 year
Adverse events (AEs)
Time frame: Up to 5 years
Perioperative complications rate
Time frame: Up to 3 years
Health-related Quality of Life
Time frame: Up to 5 years
Perioperative pain evaluation
Time frame: Up to 3 years
Disease free survival (DFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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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.
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 Lung Squamous Cell Carcinoma, run by Second Xiangya Hospital of Central South University 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Hu, M.D., Ph.D. (8685296122, yanhu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic completet response (pCR) rate (time frame: Up to 1 year). The study lists 4 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 21 Mar 2023.