Clinical trial NCT05495672: Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Colorectal Cancer
Circulating Tumor DNA
Keywords: advanced colorectal cancer
lung metastasis
circulating tumor DNA
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai OrigiMed Co., Ltd.
First posted: 2022-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies
timeFrame: From date of treatment until the date of first documented progression or date of death from any cause, assessed up to 36 months.
Secondary outcomes:
measure: ctDNA positive rate in colorectal cancer patients with metastatic small pulmonary nodules
timeFrame: 4 weeks
measure: ctDNA positive prediction rate (Consistent with histopathological result as the standard for comparison)
timeFrame: 8 weeks
measure: The ctDNA clearance rate after local treatment
timeFrame: 8 weeks
measure: The ctDNA clearance rate after chemotherapy in patients achieving NED (Cohort 2)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: