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Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

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

Study Description
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Brief Summary:
A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Oligometastatic Disease Genetic: ctDNA testing and whole exome sequencing

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
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
oligometastatic disease
Dynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis.
 Genetic: ctDNA testing and whole exome sequencing
Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.


Biospecimen Retention:   Samples With DNA
Every ctDNA test will take 20ml peripheral blood for DNA extraction.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05648370


Contacts
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Contact: Wen-Zhao Zhong, Ph.D +86 02083827812 syzhongwenzhao@scut.edu.cn
Contact: Rui Fu, M.D. +86 02083827812 ruifu66@foxmail.com

Locations
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China, Guangdong
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wen-Zhao Zhong, Ph.D    +86 02083827812    syzhongwenzhao@scut.edu.cn   
Contact: Rui Fu, M.D.    +86 02083827812    ruifu66@foxmail.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: Wen-Zhao Zhong, Ph.D Guangdong Provincial People's Hospital
More Information
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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT05648370    
Other Study ID Numbers: LB4S
First Posted: December 13, 2022    Key Record Dates
Last Update Posted: December 13, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases