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

NCT ID: NCT05495672

Condition: Advanced Colorectal Cancer
Circulating Tumor DNA

Conditions: Official terms:
Colorectal Neoplasms
Multiple Pulmonary Nodules

Conditions: Keywords:
advanced colorectal cancer
lung metastasis
circulating tumor DNA

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Local treatment
Description: Radical surgical resection, local radiotherapy, radiofrequency ablation (RFA) or interventional therapy (absolute alcohol or cryotherapy). The equipment used for RFA of lung lesions consisted of the radiofrequency generator (CelonLab POWER), cold circulation pump (Celon Aquaflow Ⅲ), radiofrequency needle electrode (Celon proSurge: T20, T30 and T40 is an electrode length of 20, 30 and 40 mm respectively, and maximum output power of 20, 30 and 40 W; Olympus Surgical Technologies Europe, Hamburg, Germany).
Arm group label: Cohort 1-Arm A: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA positive
Arm group label: Cohort 2-Arm C: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA positive

Summary: The clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Postoperative ctDNA in colorectal cancer patients is a valuable biomarker to identify minimal residual disease (MRD) after radical resection, which is possibly useful in redefining the risk group of patients and guiding postoperative treatment. This study aimed to explore the clinical value of therapeutic strategies based on tumor-informed ctDNA test in advanved colorectal cancer patients with small pulmonary nodules.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Country: China

Status: Recruiting

Start date: August 1, 2022

Completion date: December 1, 2025

Lead sponsor:
Agency: Junjie Peng
Agency class: Other

Collaborator:
Agency: Shanghai OrigiMed Co., Ltd.
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05495672

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