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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