Using blood tests to guide treatment for colorectal cancer patients with small lung nodules

Circulating Tumor DNA Guided Therapeutic Strategies for Colorectal Cancer Patients With Small Pulmonary Nodules Suspected to be Metastases: an Open-Label, Prospective, Phase II Cohort Study

This study is testing whether blood tests can help doctors decide the best treatment for colorectal cancer patients who have small lung nodules that might be cancer spread.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05495672 on ClinicalTrials.gov

What this trial studies

This study investigates the use of circulating tumor DNA (ctDNA) blood testing to inform therapeutic strategies for patients with advanced colorectal cancer who have small pulmonary nodules suspected to be lung metastases. By analyzing ctDNA, the study aims to identify minimal residual disease after surgery and redefine patient risk groups, potentially guiding postoperative treatment decisions. The approach focuses on local treatments for lung lesions, which are confirmed as metastatic by imaging. The study seeks to enhance the management of advanced colorectal cancer patients with lung metastasis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with pathologically confirmed advanced colorectal cancer and small lung lesions considered metastatic.

Not a fit: Patients with lung lesions larger than 2 cm or those with other types of cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for colorectal cancer patients with lung metastases.

How similar studies have performed: Previous studies have shown promise in using ctDNA as a biomarker for cancer management, indicating potential success for this approach.

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.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Junjie Peng, MD, PhD

Conditions: Advanced Colorectal Cancer, Circulating Tumor DNA, advanced colorectal cancer, lung metastasis, circulating tumor DNA