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Significance of MRD After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC

NCT05441566 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-07-01

No results posted yet for this study

Summary

1\. It has been controversial whether adjuvant therapy should be done for patients with stage IB NSCLC after surgery in clinical practice, and identifying patients with high-risk recurrence and those who can benefit from adjuvant therapy is an important clinical problem to be solved. Therefore, the first key scientific issue to be solved in this topic is to analyze the correlation between MRD detection results and both recurrence and adjuvant therapy efficacy by focusing on the stage IB-IIA postoperative NSCLC patient population. To provide clinical data to aid clinical screening of NSCLC patients at high risk of recurrence after surgery in stage IB-IIA.

2, if the detection of MRD has important clinical value such as accurately identifying the population at high risk of recurrence of stage IB-IIA NSCLC, the differences in MRD, etc. between driver gene-positive and -negative patients require further comparative analysis. The second key scientific issue to be solved in this topic is: the different role of MRD in driver gene-positive and driver gene-negative patients: comparison of positive rates, analysis of prognostic differences; and providing clinical data for elucidating the differences between driver gene-positive and -negative patients in MRD evaluation of lung cancer.

3\. If MRD is different between NSCLC patients with positive and negative driver genes in stage IB-IIA, is there a difference in the biological behavior of the tumors themselves between these two types of patients? Is there a difference in the ability of the tumor tissue itself to shed tumor cells to be released into the blood? The third scientific question to be addressed in this project is to explore the difference in the ability of patients with stage IB-IIA NSCLC to release ctDNA from their tumors by analyzing the correlation between detailed clinicopathological data and MRD. To provide a scientific basis for exploring the differences in tumor biological behavior between NSCLC driver gene positive and negative.

Conditions

  • NSCLC MRD ctDNA

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Gui G Ding · Shenzhen People's Hospital

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441566 on ClinicalTrials.gov