NCT05648370RecruitingNot Applicable
Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
Guangdong Provincial People's Hospital1 site in 1 country60 target enrollmentStarted: July 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Association between perioperative ctDNA-MRD characteristics and rogression-free survival
Study Overview
Brief Summary
A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.
Detailed Description
60 eligible patients will be enrolled. Dynamic blood samples before and after surgery and tissue samples will be obtained for exploratory analysis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study；
- •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 confirmed or suspected autoimmune disease;
- •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;
Outcomes
Primary Outcomes
Association between perioperative ctDNA-MRD characteristics and rogression-free survival
Time Frame: 2-year PFS
To explore the potential association among perioperative ctDNA-MRD characteristics and rogression-free survival within 2 years.
Construction of a survival-prediction model
Time Frame: Through study completion, up to 5 years
The survival-prediction model based on clinicopathological and genomic characteristics.
Secondary Outcomes
- Association among ctDNA status before surgery, systemic treatment times, and survival(Through study completion, up to 5 years)
- Heterogeneity in Genomic and transcriptome between primary and metastatic tumors(60 patients underwent surgery)
- Assess whether ctDNA-MRD is associated with radiological and pathological response after systematic therapy before surgery(60 patients underwent surgery)
- Potential drug-resistance mechanism identified by plasma ctDNA(Through study completion, up to 5 years)
- Genomic characteristics and clonal evolution after systemic treatment(Through study completion, up to 5 years)
Investigators
Study Sites (1)
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