Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention

Launched by FUDAN UNIVERSITY · Nov 22, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to monitor patients with advanced colorectal cancer who have no evidence of disease (NED) after treatment. The researchers want to see if checking for circulating tumor DNA (ctDNA) in the blood can provide early information about a patient’s health status, potentially even before regular imaging scans like CT scans are done. By monitoring ctDNA, the trial aims to understand whether patients who still show signs of cancer in their blood might benefit from starting new treatments sooner.

To participate in this trial, patients need to be adults over 18 years old with late-stage colorectal cancer that may be treatable. They should be in a situation where doctors believe they can achieve no evidence of disease through targeted therapies or surgery. Participants will regularly have their blood tested to check for ctDNA. Depending on the results, they may receive personalized treatment plans or continue with standard follow-up care. This trial is currently recruiting participants, and it’s an opportunity for eligible patients to explore new ways to manage their cancer.

Gender

ALL

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.