Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358222
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-28
Brief Title:
Predicting Non-small Cell Lung Cancer NSCLC Lymph Node Metastasis Integrating Circulating Tumor DNA ctDNA Mutation Methylation Profiling With Positron Emission Tomography-computed Tomography PET-CT Scan
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Predicting NSCLC Lymph Node Metastasis Integrating ctDNA Mutation Methylation Profiling With PET-CT Scan The LUNon-invasive Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center prospective and observational study conducted in three stages to predict the NSCLC lymph node metastasis based on ctDNAspecific methylation molecular features combined with PET-CT imaging features and intervention study
Detailed Description:
This is a prospective study conducted in three stages The volume of blood drawn will be 30 mL each time
Stage 1 We will enroll 200 patients diagnosed with stage I-IIIB NSCLC who are scheduled for lobectomy and systematic lymph node dissection The prediction of lymph node metastasis will be based on preoperative blood ctDNA mutation and methylation profiling Specifically during this stage we will prospectively establish ctDNA methylation signatures specifically associated with LNMs in NSCLC These molecular profiles will be combined with PET-CT imaging Postoperative pathological results will serve as the reference standard for comparison
Stage 2 A certain number depending on the Results of Stage 1 of patients requiring invasive mediastinoscopy or EBUS-TBNA based on the clinical guidelines will be included for blood ctDNA mutationmethylation profile or combined PET-CT and the detection rate of LNMs will be assessed in patients with negative preoperative blood ctDNA mutationmethylation or combined PET-CT The accuracy of predicting LNMs will be compared with that of patients with negative or positive preoperative blood ctDNA mutationmethylation or combined PET-CT
Stage 3 For patients with negative preoperative blood negative testing ctDNA mutationmethylation profiles alone or in combination with PET-CT systematic lymph node samplingdissection and no lymph node dissection will be grouped and compared Regular follow-up is performed to investigate the impact on long-term MRD negative duration and prognosis The primary outcomes postoperative MRD negative duration and progression-free survival PFS The second outcomes Overall survival OS
Stage 1 We will enroll 200 patients diagnosed with stage I-IIIB NSCLC who are scheduled for lobectomy and systematic lymph node dissection The prediction of lymph node metastasis will be based on preoperative blood ctDNA mutation and methylation profiling Specifically during this stage we will prospectively establish ctDNA methylation signatures specifically associated with LNMs in NSCLC These molecular profiles will be combined with PET-CT imaging Postoperative pathological results will serve as the reference standard for comparison
Stage 2 A certain number depending on the Results of Stage 1 of patients requiring invasive mediastinoscopy or EBUS-TBNA based on the clinical guidelines will be included for blood ctDNA mutationmethylation profile or combined PET-CT and the detection rate of LNMs will be assessed in patients with negative preoperative blood ctDNA mutationmethylation or combined PET-CT The accuracy of predicting LNMs will be compared with that of patients with negative or positive preoperative blood ctDNA mutationmethylation or combined PET-CT
Stage 3 For patients with negative preoperative blood negative testing ctDNA mutationmethylation profiles alone or in combination with PET-CT systematic lymph node samplingdissection and no lymph node dissection will be grouped and compared Regular follow-up is performed to investigate the impact on long-term MRD negative duration and prognosis The primary outcomes postoperative MRD negative duration and progression-free survival PFS The second outcomes Overall survival OS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None