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Trial Title:
Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
NCT ID:
NCT05648370
Condition:
Non-small Cell Lung Cancer
Oligometastatic Disease
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
ctDNA testing and whole exome sequencing
Description:
Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome
sequencing.
Arm group label:
oligometastatic disease
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.
Criteria for eligibility:
Study pop:
Stage IV NSCLC patients with oligometastases at initial diagnosis or oligoresidual or
oligoprogression or oligorelapses after systemic therapy
Sampling method:
Non-Probability Sample
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen-Zhao Zhong, Ph.D
Phone:
+86 02083827812
Email:
syzhongwenzhao@scut.edu.cn
Contact backup:
Last name:
Rui Fu, M.D.
Phone:
+86 02083827812
Email:
ruifu66@foxmail.com
Start date:
July 1, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05648370
