Using ctDNA to monitor disease status in metastatic colorectal cancer

Predictive Value of Circulating Tumor DNA (ctDNA) for no Evidence of Disease (NED) Status in Metastatic Colorectal Cancer (mCRC) and Its Utility in Guiding Therapeutic Intervention: an Open-label, Prospective, Phase II Cohort Study

This study is testing if tracking circulating tumor DNA can help doctors better monitor patients with metastatic colorectal cancer who have no signs of disease and see if those with positive results can benefit from early treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05635630 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the prognostic value of circulating tumor DNA (ctDNA) monitoring in patients with metastatic colorectal cancer (mCRC) who have no evidence of disease (NED) status. It seeks to determine if ctDNA can assess NED status more effectively than traditional radiologic methods and whether patients with positive ctDNA results can benefit from early therapeutic interventions. Participants will undergo longitudinal ctDNA monitoring and will be categorized into ctDNA positive or negative groups to tailor their treatment plans accordingly.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with late-stage metastatic colorectal adenocarcinoma who have the potential to achieve NED status.

Not a fit: Patients with early-stage colorectal cancer (cTNM stage I-III) or those unable to obtain a histologic or cytologic diagnosis may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring disease status, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Age \> 18 years old. Both male and female are eligible.
2. Late stage metastatic colorectal adenocarcinoma diagnosed by histology or cytology.
3. With potential opportunity of achieving NED status (including liver metastasis, lung metastasis, solitary lymph node metastasis, ovarian metastasis or focal pelvic metastasis), regardless of neo-adjuvant therapy or transforming therapy.
4. Patients who are intended for focal therapy, radical surgery, focal radiotherapy, radiofrequency ablation or interventional therapy (anhydrous alcohol injection or cryotherapy)
5. Eastern Cooperative Oncology Group (ECOG) grade 1-2.
6. Approve the informed consent.
7. Available for tumor sample obtained by resection or aspiration.
8. Available for peripheral blood collection (10mL per tube for 2 tubes)

Exclusion Criteria:

1. Cannot get histologic or cytologic diagnosis.
2. Clinical tumor, node, and metastasis (cTNM) stage I-III according to the American Joint Committee on Cancer (AJCC), the 8th edition.
3. Accompany with widespread metastasis and cannot achieve NED status by focal therapy, such as bone metastasis, peritoneum metastasis, diffuse liver or lung metastasis or malignant effusion, etc.
4. Inadequate bone marrow reserve and organ function.
5. Uncontrolled or severe systemic diseases, such as uncontrolled hyperplasia, severe infection, hepatitic B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, etc.
6. History of alcohol or drug abuse.
7. Pregnant or lactating women.
8. Cannot get tumor sample.

Where this trial is running

Shanghai, Shanghai

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

Study contacts

• Study coordinator: Junjie Peng

Conditions Metastatic Colorectal Cancer; No Evidence of Disease Status; ctDNA Monitoring