Status:
RECRUITING
MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC
Lead Sponsor:
Jiangsu Cancer Institute & Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC no...
Detailed Description
This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To eva...
Eligibility Criteria
Inclusion
- Written informed consent must be signed before implementing any enrollment-related procedures;
- Age ≥18 years old;
- Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging);
- There is no special restriction on the source of genetic test report.
- According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
- Have not received any previous systemic antitumor therapy for advanced diseases.
- No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
- ECOG score: 0-1;
- Expected survival time \> 3 months.
Exclusion
- Received surgical treatment for lung tumors.
- Received neoadjuvant chemotherapy or radiotherapy.
- Received cellular therapy within the last 1 year.
- Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
- Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06198868
Start Date
February 1 2024
End Date
February 1 2027
Last Update
January 12 2024
Active Locations (1)
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1
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China, 210009