Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
NCT ID: NCT05648370
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
60 participants
OBSERVATIONAL
2022-07-01
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
oligometastatic disease
Dynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis.
ctDNA testing and whole exome sequencing
Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ctDNA testing and whole exome sequencing
Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must be a man or woman of more than 18 years;
* ECOG PS ≦1；
* The function of the organs was evaluated by the surgeon to tolerate local surgical treatment；
* The classification was evaluated as simultaneous oligometastases at initial treatment or oligoresidual/oligoprogression/oligorecurrence after induction therapy; \[Define: Initial treatment of simultaneous oligometastases: without systemic treatment, at the time of diagnosis, up to 5 metastases and up to 3 organs were involved, excluding pleural metastases or myeloid metastases.
Oligoresidual after induction therapy: after systemic therapy, distant metastases were stable or reduced, primary lesions were stable or reduced, PET/CT metabolism was reduced, and no more than 5 residual lesions and no more than 3 organs were involved.
Oligoprogression after induction therapy: After systemic therapy, some lesions were stable or reduced, while some original lesions were larger than before.
Oligorelapses after induction therapy: after systemic therapy, systemic lesions were stable or reduced, and new local lesions appeared.\]
* Lesion evaluation can be surgically removed. \[Definition of operable resection: the lesion is limited and can be completely removed through surgery as assessed by the surgeon, with no significant impact on postoperative quality of life. Pulmonary surgical procedures include lobectomy, segmental resection and wedge resection. Pneumonectomy is not included.\]
Exclusion Criteria
* Patients with a history of human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS);
* Patients with a history of any arterial thrombosis within 6 months and history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months;
* Patients with any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.);
* Patients with a history of other malignancies in the past 5 years;
* Patients identified by the investigators patients with contraindications to local treatment;
* Patients with serious mental illness;
* Patients who cannot sign informed consent;
* Patients who cannot be followed up as scheduled;
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangdong Provincial People's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wen-Zhao Zhong, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Wen-Zhao Zhong, Ph.D
Role: primary
Rui Fu, M.D.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LB4S
Identifier Type: -
Identifier Source: org_study_id