Back to resultsPredictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention
Primary Purpose
Metastatic Colorectal Cancer, No Evidence of Disease Status, ctDNA Monitoring
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ctDNA and adjuvant therapy
ctDNA
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: Age > 18 years old. Both male and female are eligible. Late stage metastatic colorectal adenocarcinoma diagnosed by histology or cytology. 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. Patients who are intended for focal therapy, radical surgery, focal radiotherapy, radiofrequency ablation or interventional therapy (anhydrous alcohol injection or cryotherapy) Eastern Cooperative Oncology Group (ECOG) grade 1-2. Approve the informed consent. Available for tumor sample obtained by resection or aspiration. Available for peripheral blood collection (10mL per tube for 2 tubes) Exclusion Criteria: Cannot get histologic or cytologic diagnosis. Clinical tumor, node, and metastasis (cTNM) stage I-III according to the American Joint Committee on Cancer (AJCC), the 8th edition. 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. Inadequate bone marrow reserve and organ function. 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. History of alcohol or drug abuse. Pregnant or lactating women. Cannot get tumor sample.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ctDNA positive
ctDNA negative
Arm Description
Outcomes
Primary Outcome Measures
Relapse-free survival (RFS) time
To detect the RFS time in metastatic colorectal cancer (mCRC) patients with no evidence of disease (NED) status who received circulating tumor DNA (ctDNA) guided therapies.
Secondary Outcome Measures
Overall survival (OS) time
To detect the OS time in mCRC patients with NED status who received ctDNA guided therapies.
The positive rate of ctDNA in mCRC patients with NED status.
When the NED status is confirmed by radiology post-operation, it will also be assessed the ctDNA positive rate.
The concordance index of ctDNA defined NED and radiology defined NED status.
In this study, we aim to evaluate the NED status by ctDNA and traditional radiologic methods. The concordance index will be used to detect the identity of two methods.
The rate of achieving NED status when relapses happen.
When the diseases relapse during the follow-up. The multi-disciplinary treatment (MDT) team will discuss the opportunities to achieve a second NED status.
Full Information
NCT ID
NCT05635630
First Posted
November 3, 2022
Last Updated
November 22, 2022
Sponsor
Fudan University
Collaborators
Guangzhou Burning Rock Dx Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05635630
Brief Title
Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
December 24, 2023 (Anticipated)
Study Completion Date
December 24, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Guangzhou Burning Rock Dx Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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:
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer, No Evidence of Disease Status, ctDNA Monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ctDNA positive
Arm Type
Experimental
Arm Title
ctDNA negative
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ctDNA and adjuvant therapy
Intervention Description
Patients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months.
Intervention Type
Other
Intervention Name(s)
ctDNA
Intervention Description
Patients of ctDNA negative group are monitored by ctDNA every 3 months.
Primary Outcome Measure Information:
Title
Relapse-free survival (RFS) time
Description
To detect the RFS time in metastatic colorectal cancer (mCRC) patients with no evidence of disease (NED) status who received circulating tumor DNA (ctDNA) guided therapies.
Time Frame
From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Secondary Outcome Measure Information:
Title
Overall survival (OS) time
Description
To detect the OS time in mCRC patients with NED status who received ctDNA guided therapies.
Time Frame
From the date of surgery until the date of death from any cause, assessed up to 2 years.
Title
The positive rate of ctDNA in mCRC patients with NED status.
Description
When the NED status is confirmed by radiology post-operation, it will also be assessed the ctDNA positive rate.
Time Frame
Post-operation 1 month
Title
The concordance index of ctDNA defined NED and radiology defined NED status.
Description
In this study, we aim to evaluate the NED status by ctDNA and traditional radiologic methods. The concordance index will be used to detect the identity of two methods.
Time Frame
When the clinic trail is finished, up to 2 years.
Title
The rate of achieving NED status when relapses happen.
Description
When the diseases relapse during the follow-up. The multi-disciplinary treatment (MDT) team will discuss the opportunities to achieve a second NED status.
Time Frame
When the relapses happen, up to 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years old. Both male and female are eligible.
Late stage metastatic colorectal adenocarcinoma diagnosed by histology or cytology.
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.
Patients who are intended for focal therapy, radical surgery, focal radiotherapy, radiofrequency ablation or interventional therapy (anhydrous alcohol injection or cryotherapy)
Eastern Cooperative Oncology Group (ECOG) grade 1-2.
Approve the informed consent.
Available for tumor sample obtained by resection or aspiration.
Available for peripheral blood collection (10mL per tube for 2 tubes)
Exclusion Criteria:
Cannot get histologic or cytologic diagnosis.
Clinical tumor, node, and metastasis (cTNM) stage I-III according to the American Joint Committee on Cancer (AJCC), the 8th edition.
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.
Inadequate bone marrow reserve and organ function.
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.
History of alcohol or drug abuse.
Pregnant or lactating women.
Cannot get tumor sample.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junjie Peng
Phone
+86-021-64175590
Email
pengjj67@hotmail.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junjie Peng
Phone
021-64175590
Email
pengjj67@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention
We'll reach out to this number within 24 hrs