Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

• ClinicalTrials.gov Identifier: NCT05648370
• Recruitment Status: Recruiting
• First Posted: December 13, 2022
• Last Update Posted: December 13, 2022
• Sponsor: Guangdong Provincial People's Hospital
• Information provided by (Responsible Party): Guangdong Provincial People's Hospital

Tracking Information

• First Submitted Date: December 5, 2022
• First Posted Date: December 13, 2022
• Last Update Posted Date: December 13, 2022
• Actual Study Start Date: July 1, 2022
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2022)

• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 5, 2022)

• Association among ctDNA status before surgery, systemic treatment times, and survival [ Time Frame: Through study completion, up to 5 years ]
  To explore the potential association among plasma ctDNA status surgery, systemic treatment time duration, PFS and OS.
• Genomic characteristics and clonal evolution after systemic treatment [ Time Frame: Through study completion, up to 5 years ]
  Using whole-exome sequencing to identify genomic characteristics and clonal evolution after systemic treatment
• Potential drug-resistance mechanism identified by plasma ctDNA [ Time Frame: Through study completion, up to 5 years ]
  Using plasma ctDNA-MRD to identify the potential drug-resistance mechanism.
• Assess whether ctDNA-MRD is associated with radiological and pathological response after systematic therapy before surgery [ Time Frame: 60 patients underwent surgery ]
  Association among perioperative ctDNA-MRD characteristics, imaging response, and pathological response.
• Heterogeneity in Genomic and transcriptome between primary and metastatic tumors [ Time Frame: 60 patients underwent surgery ]
  Using whole-exome sequencing and whole transcriptome sequencing to identify genomic and transcriptome heterogeneity between primary and metastatic tumors.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
• Official Title: Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Every ctDNA test will take 20ml peripheral blood for DNA extraction.

• Sampling Method: Non-Probability Sample
• Study Population: Stage IV NSCLC patients with oligometastases at initial diagnosis or oligoresidual or oligoprogression or oligorelapses after systemic therapy

Condition

• Non-small Cell Lung Cancer
• Oligometastatic Disease

Intervention

Genetic: ctDNA testing and whole exome sequencing

Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing.

Study Groups/Cohorts

oligometastatic disease

Dynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis.

Intervention: Genetic: ctDNA testing and whole exome sequencing

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 5, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Wen-Zhao Zhong, Ph.D; +86 02083827812; syzhongwenzhao@scut.edu.cn

Contact: Rui Fu, M.D.; +86 02083827812; ruifu66@foxmail.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05648370
• Other Study ID Numbers: LB4S
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Guangdong Provincial People's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Guangdong Provincial People's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wen-Zhao Zhong, Ph.D; Guangdong Provincial People's Hospital

• PRS Account: Guangdong Provincial People's Hospital
• Verification Date: July 2022