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

NCT05495672•Junjie Peng

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

August 1, 2022

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2025

Last Updated

August 10, 2022

Enrollment

100

ESTIMATED participants

Conditions

Advanced Colorectal CancerCirculating Tumor DNA

Interventions

Local treatment

PROCEDURE

Contacts

Junjie Peng, MD, PhD

CONTACT

86-18017317122 pengjj67@hotmail.com

Wenhua Li, MD, PhD

CONTACT

13817922257 whliiris@hotmail.com

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

NCT07321106

Colorectal CancerColorectal Cancer (CRC)+5 more

View study

RECRUITING

Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling

NCT07310537

Colorectal Cancer (Diagnosis)Colorectal Liver Metastasis (CRLM)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling

Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer

Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer

Using ctDNA to Determine Therapies for Lung Cancer

Danish Vulva Cancer Recurrence Study