Monitoring molecular residual disease in lung cancer patients after surgery
Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
This study is testing a new way to check for leftover cancer cells in the blood and tissue of lung cancer patients after surgery to see if it can help predict and manage their chances of recurrence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 377 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05965024 on ClinicalTrials.gov |
What this trial studies
This study focuses on using a specialized monitoring panel based on patented sequencing technology to detect molecular residual disease (MRD) in patients with stage IB-IIIB non-small cell lung cancer who have undergone radical surgery. By analyzing lung cancer tissue and blood samples, the study aims to explore personalized models for predicting recurrence and improve monitoring strategies for these patients. The observational approach allows for the collection of data on the effectiveness of MRD detection in managing post-surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of stage IB-IIIB non-small cell lung cancer who are eligible for radical surgery.
Not a fit: Patients with a history of other malignancies, those who have undergone neoadjuvant therapy, or individuals with serious organ diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and early detection of cancer recurrence in lung cancer patients, potentially enhancing survival rates.
How similar studies have performed: While the approach of using ctDNA for MRD detection is gaining traction, this specific application in non-small cell lung cancer is still being explored and may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old, regardless of gender; 2. Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB; 3. Able to undergo radical surgical treatment; 4. Physical condition score (ECOG) ≤1; 5. The expected survival time exceeds 24 months; 6. Volunteer to participate in this study and sign an informed consent form. Exclusion Criteria: 1. Individuals with a history of other malignant tumors within 5 years; 2. Those who have undergone neoadjuvant therapy before surgery; 3. Postoperative incision margin R1 or incision margin R2; 4. Those who have undergone a blood transfusion within 2 weeks before the surgery; 5. Individuals with systemic inflammatory response syndrome; 6. Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain; 7. Participants in other clinical trials within the past 30 days and have taken investigational drugs; 8. Due to various reasons, sampling cannot be completed, samples do not meet the requirements, or baseline samples (preoperative and postoperative plasma samples, tumor tissue samples) are incomplete; 9. Researchers believe that it is not appropriate to participate in this experiment.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.