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

November 22, 2022 updated by: Junjie Peng, Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ctDNA positive
Other: ctDNA and adjuvant therapy
Patients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months.
Experimental: ctDNA negative
Other: ctDNA
Patients of ctDNA negative group are monitored by ctDNA every 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival (RFS) time
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.
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS) time
Time Frame: From the date of surgery until the date of death from any cause, assessed up to 2 years.
To detect the OS time in mCRC patients with NED status who received ctDNA guided therapies.
From the date of surgery until the date of death from any cause, assessed up to 2 years.
The positive rate of ctDNA in mCRC patients with NED status.
Time Frame: Post-operation 1 month
When the NED status is confirmed by radiology post-operation, it will also be assessed the ctDNA positive rate.
Post-operation 1 month
The concordance index of ctDNA defined NED and radiology defined NED status.
Time Frame: When the clinic trail is finished, up to 2 years.
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.
When the clinic trail is finished, up to 2 years.
The rate of achieving NED status when relapses happen.
Time Frame: When the relapses happen, up to 2 years.
When the diseases relapse during the follow-up. The multi-disciplinary treatment (MDT) team will discuss the opportunities to achieve a second NED status.
When the relapses happen, up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Guangzhou Burning Rock Dx Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2022

Primary Completion (Anticipated)

December 24, 2023

Study Completion (Anticipated)

December 24, 2025

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ctDNA-nedCRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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