Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules

Launched by JUNJIE PENG · Aug 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how using a special blood test, called circulating tumor DNA (ctDNA) testing, can help doctors make better treatment decisions for patients with advanced colorectal cancer who have small lung nodules that may be cancer spread. The main goal is to see if this test can accurately identify any remaining cancer after surgery and help guide further treatment for those patients.

To participate in this study, patients need to be between 18 and 80 years old and have been diagnosed with advanced colorectal cancer that has spread to the lungs. They should have small lung nodules that can be treated with specific procedures. Participants will undergo blood tests and potentially have surgery or other treatments based on what the ctDNA test shows. It's important to know that this research is still in the recruiting phase, and participants are expected to follow up for at least two years to track their health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 and ≤80 years old, regardless of gender;
• • 2. Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;
• • 3. Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;
• • 4. Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;
• • 5. For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);
• • 6. Eastern Cooperative Oncology Group (ECOG) score 1 \~ 2;
• • 7. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study;
• • 8. Surgical specimens or puncture specimens containing tumor tissue are available;
• • 9. 20 mL of peripheral blood are available (10 mL per tube, two tubes in total);
• • 10. Agreed to follow up for at least 2 years.
• Exclusion Criteria:
• • 1. The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;
• • 2. Patients with stage I-III colorectal cancer;
• • 3. Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;
• • 4. Presence of metastasis other than lung;
• • 5. Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;
• • 6. Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus;
• • 7. History of alcoholism or drug abuse;
• • 8. Pregnant or lactating patients.