Lung Cancer (NSCLC)NCT07186855
Perioperative and Postoperative Circulating Tumor Cell Monitoring in Different Stage of NSCLC
An observational study of Lung Cancer (NSCLC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The study aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs, and comprehensively assess the utility of this CTC monitoring technology in predicting postoperative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Blood Sample Collection for CTC Detection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Sep 2024
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: A total of 500 non-small cell lung cancer patients undergoing surgical treatment will be enrolled from the Department of Thoracic Surgery at the Cancer Hospital, Chinese Academy of Medical Sciences, and its affiliated centers.Among them, approximately 180 cases will be early-stage.
Who may be able to join
- (1) Age of the patient: ≥18 and ≤75 years; (2) No prior anticancer treatment before surgery; (3) No history of other tumors, past or concurrent; (4) Underwent radical surgery for lung cancer between November 2020 and October 2022; (5) Postoperative pathological diagnosis of non-small cell lung cancer, with staging between Ia and IIIb; (6) Able to comply with study requirements and has signed informed consent.
Who cannot join
- (1) Patients with non-small cell lung cancer who have received tumor-related treatments before surgery (including chemotherapy, radiotherapy, targeted therapy, and immunotherapy); (2) Patients with severe cardiac, pulmonary, hepatic, cerebral, or renal dysfunction who are unable to tolerate surgery; (3) Pregnant patients; (4) Patients with concurrent other malignancies; (5) Patients with severe underlying diseases that make them unable to tolerate surgery; (6) Patients with types of lung cancer other than non-small cell lung cancer or with secondary malignant tumors in the lung.
Trial locations and contacts
1 site in 1 country.
China1 site
Nationa Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijingn, 100021
About this study
Official title: The Study on the Relationship Between Perioperative and Postoperative Circulating Tumor Cell Monitoring and Prognosis in Patients With Non-Small Cell Lung Cancer at Different Stages
The study aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs, and comprehensively assess the utility of this CTC monitoring technology in predicting postoperative recurrence, metastasis, and survival in non-small cell lung cancer patients across different stages.
Read the detailed description
Lung cancer currently has the highest incidence and mortality rates among malignant tumors in China. Distant metastasis is one of the main causes of death in lung cancer patients, with hematogenous dissemination being the primary pathway for lung cancer metastasis. Theoretically, even at the carcinoma in situ stage, cancer cells can disseminate into the peripheral blood, forming circulating tumor cells (CTCs), thus playing a critical role in the process of distant metastasis in lung cancer. Early diagnosis and monitoring of recurrence and metastasis are essential for improving patient survival rates. Traditional methods for monitoring postoperative recurrence and metastasis in lung cancer patients rely primarily on imaging studies; however, by the time recurrence or metastasis is detected through imaging, the disease is often at an advanced stage, leading to suboptimal treatment outcomes. Previous studies have shown that changes in CTC levels usually precede the appearance of detectable lesions on imaging. Therefore, CTC level monitoring can predict recurrence, metastasis, treatment response, and prognosis in lung cancer patients.
As a form of "liquid biopsy," CTC testing can provide timely insights into a patient's disease status and offer better individualized treatment strategies for lung cancer patients. This study utilizes the viral tracing method developed by our research team, which holds independent intellectual property rights, as the primary technology. In addition, microfluidic technology has been introduced upstream in the workflow to initially screen and enrich CTCs, followed by ex vivo identification and characterization of the captured CTCs. The study aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs. Finally, by integrating preoperative and postoperative imaging data, pathological findings, and recurrence, metastasis, and survival outcomes, we will comprehensively assess the utility of this CTC monitoring technology in predicting postoperative recurrence, metastasis, and survival in non-small cell lung cancer patients across different stages.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Blood Sample Collection for CTC Detection
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample Collection for CTC DetectionOther
Blood Sample Collection for CTC Detection
| Study group | Role | What they receive |
|---|---|---|
| early-stage NSCLC | CTC detection will be conducted on 180 cases. Receives: Other: Blood Sample Collection for CTC Detection | |
| Advanced-Stage Non-Small Cell Lung Cancer | CTC detection will be conducted on 320 cases. Receives: Other: Blood Sample Collection for CTC Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-Year Recurrence Status
Time from surgery util recurrence
Measured: Up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2021
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YOUSHAN MAO, MD, Study director, NCC, CICAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186855
- Sponsor's protocol ID
- LC2020L02
- Status last verified
- Oct 2020
- First submitted
- 16 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with relevant laws and regulations, researchers who wish to access the raw data should contact the principal investigator via email.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Relationship Between Perioperative and Postoperative Circulating Tumor Cell Monitoring and Prognosis in Patients With Non-Small Cell Lung Cancer at Different Stages
- ClinicalTrials.gov ID
- NCT07186855
- Acronym / sponsor ID
- LC2020L02
- Conditions
- Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 22 Sep 2025 (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 aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs, and comprehensively assess the utility of this CTC monitoring technology in predicting postoperative recurrence, metastasis, and survival in non-small cell lung cancer patients across different stages.
Detailed description
Lung cancer currently has the highest incidence and mortality rates among malignant tumors in China. Distant metastasis is one of the main causes of death in lung cancer patients, with hematogenous dissemination being the primary pathway for lung cancer metastasis. Theoretically, even at the carcinoma in situ stage, cancer cells can disseminate into the peripheral blood, forming circulating tumor cells (CTCs), thus playing a critical role in the process of distant metastasis in lung cancer. Early diagnosis and monitoring of recurrence and metastasis are essential for improving patient survival rates. Traditional methods for monitoring postoperative recurrence and metastasis in lung cancer patients rely primarily on imaging studies; however, by the time recurrence or metastasis is detected through imaging, the disease is often at an advanced stage, leading to suboptimal treatment outcomes. Previous studies have shown that changes in CTC levels usually precede the appearance of detectable lesions on imaging. Therefore, CTC level monitoring can predict recurrence, metastasis, treatment response, and prognosis in lung cancer patients.
As a form of "liquid biopsy," CTC testing can provide timely insights into a patient's disease status and offer better individualized treatment strategies for lung cancer patients. This study utilizes the viral tracing method developed by our research team, which holds independent intellectual property rights, as the primary technology. In addition, microfluidic technology has been introduced upstream in the workflow to initially screen and enrich CTCs, followed by ex vivo identification and characterization of the captured CTCs. The study aims to enroll 500 non-small cell lung cancer patients at various stages and to employ this technology for CTC detection, with subsequent cytomorphological and chromosomal analysis of the isolated CTCs. Finally, by integrating preoperative and postoperative imaging data, pathological findings, and recurrence, metastasis, and survival outcomes, we will comprehensively assess the utility of this CTC monitoring technology in predicting postoperative recurrence, metastasis, and survival in non-small cell lung cancer patients across different stages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early-stage NSCLC | – | Other: Blood Sample Collection for CTC DetectionCTC detection will be conducted on 180 cases. |
| Advanced-Stage Non-Small Cell Lung Cancer | – | Other: Blood Sample Collection for CTC DetectionCTC detection will be conducted on 320 cases. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 500 non-small cell lung cancer patients undergoing surgical treatment will be enrolled from the Department of Thoracic Surgery at the Cancer Hospital, Chinese Academy of Medical Sciences, and its affiliated centers.Among them, approximately 180 cases will be early-stage.
Key inclusion criteria (1 listed)
- (1) Age of the patient: ≥18 and ≤75 years; (2) No prior anticancer treatment before surgery; (3) No history of other tumors, past or concurrent; (4) Underwent radical surgery for lung cancer between November 2020 and October 2022; (5) Postoperative pathological diagnosis of non-small cell lung cancer, with staging between Ia and IIIb; (6) Able to comply with study requirements and has signed informed consent.
Key exclusion criteria (1 listed)
- (1) Patients with non-small cell lung cancer who have received tumor-related treatments before surgery (including chemotherapy, radiotherapy, targeted therapy, and immunotherapy); (2) Patients with severe cardiac, pulmonary, hepatic, cerebral, or renal dysfunction who are unable to tolerate surgery; (3) Pregnant patients; (4) Patients with concurrent other malignancies; (5) Patients with severe underlying diseases that make them unable to tolerate surgery; (6) Patients with types of lung cancer other than non-small cell lung cancer or with secondary malignant tumors in the lung.
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 |
|---|---|---|
| Blood Sample Collection for CTC DetectionBlood Sample Collection for CTC Detection | Other | Advanced-Stage Non-Small Cell Lung Cancer, early-stage NSCLC |
Primary outcome
Two-Year Recurrence Status
Time frame: Up to 2 years after surgery
Time from surgery util recurrence
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 22 Sep 2025.
- Individual participant dataSharing planned: No. In accordance with relevant laws and regulations, researchers who wish to access the raw data should contact the principal investigator via email.
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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.
YOUSHAN MAO, MD study director
NCC, CICAMS
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 Cancer (NSCLC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 1 inclusion and 1 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 22 Sep 2025. 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?
Two-Year Recurrence Status (time frame: Up to 2 years after surgery). 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 22 Sep 2025.