Status:
ENROLLING_BY_INVITATION
Significance of MRD After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC
Lead Sponsor:
Shenzhen People's Hospital
Conditions:
NSCLC MRD ctDNA
Eligibility:
All Genders
18-100 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05441566
Start Date
June 1 2022
End Date
December 31 2026
Last Update
July 1 2022
Active Locations (1)
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1
ShenzhenPH
Shenzhen, China