Enrolling by Invitation

NCT Number: NCT05441566

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

NSCLC MRD ctDNA

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ShenzhenPH

Shenzhen, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with stage I-II operable NSCLC in AJCC TNM stage (8th edition) confirmed by clinical pathological staging;
The physical condition and organ function allow surgery and postoperative adjuvant therapy；
At the time of signing the informed consent form, the age is equal to or greater than 18 years old;
Tumor histology or cytology confirmed NSCLC;
Never received any surgery, radiotherapy, chemotherapy or molecular targeted anti-tumor therapy;
Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 ~ 1 points;
Patients agree and have the ability to follow the planned study visits, treatment plan, laboratory tests and other research steps;
Expected survival time ≥ 6 months.

Exclusion criteria

Patients with other malignant tumors;
Patients with inoperable clinical evaluation;
Patients with other serious diseases that may affect follow-up and significant short-term survival;
Patients who have received previous anti-tumor treatment such as surgery, chemotherapy, targeted or immunotherapy;
Eastern Cooperative Oncology Group performance status score (ECOG PS) > 2 points;
Patients with clinically clear active infection, including but not limited to pneumonia;
Any other condition and social/psychological problems, etc., judged by the investigator that the patient is not suitable for participating in this study; can not accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT) for clinical follow-up;
Other researchers think it is not suitable;
or can not comply with the study protocol.

Treatment and study plan

Primary outcomes

Changes in ctDNA levels after surgery 2 years

Time frame: baseline and 2 years

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

Dynamic Monitoring and Significance of Molecular Residual Disease After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Jul 1, 2022
Registry last updated: Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.