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

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

NCT ID: NCT05635630

Condition: Metastatic Colorectal Cancer
No Evidence of Disease Status
ctDNA Monitoring

Conditions: Official terms:
Colorectal Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: ctDNA and adjuvant therapy
Description: Patients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months.
Arm group label: ctDNA positive

Intervention type: Other
Intervention name: ctDNA
Description: Patients of ctDNA negative group are monitored by ctDNA every 3 months.
Arm group label: ctDNA negative

Summary: The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are: 1. Whether ctDNA monitoring could evaluate NED status ahead of normal radiologic monitoring. What about the concordance of evaluating NED status by ctDNA monitoring compared with normal radiologic monitoring? 2. Whether the patients with ctDNA positive status could benefit from early therapeutic intervention. Patients who receive any kinds of therapies with the aim of NED and are confirmed by clinical and radiologic examination will go through longitudinal ctDNA monitoring. According to the results of ctDNA monitoring, the patients will be divided into ctDNA positive group and ctDNA negative group. Patients in ctDNA positive group will receive individual therapeutic plan decided by the investigator. Patients in ctDNA negative group will receive regular examinations. When radiologic recurrences are confirmed, the patients will be re-evaluated for a second opportunity of radical resection.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200000
Country: China

Status: Recruiting

Contact:
Last name: Junjie Peng

Phone: 021-64175590
Email: pengjj67@hotmail.com

Start date: June 24, 2022

Completion date: December 24, 2025

Lead sponsor:
Agency: Fudan University
Agency class: Other

Collaborator:
Agency: Guangzhou Burning Rock Dx Co., Ltd.
Agency class: Industry

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05635630