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The Value of ctDNA on Chemotherapy Efficacy for mCRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555369
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Weijian Guo, Fudan University

Study Description
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Brief Summary:
The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Circulating Tumor DNA Genetic: ct-DNA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study on the Efficacy of Chemotherapy for Metastatic Colorectal Cancer Evaluated by Circulating Tumor DNA
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ct-DNA
The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.
 Genetic: ct-DNA
The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.
Other Name: circulating tumor DNA


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 2 months ]
    the response rate predicted by ct-DNA


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 months ]
  2. Overall survival [ Time Frame: 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555369


Contacts
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Contact: Weijian Guo, phD 8621-64175590 iamchangjinjia@163.com
Contact: Weijian Guo 8621-64175590 iamchangjinjia@163.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jinjia Chang, MD,PhD       iamchangjinjia@163.com   
Principal Investigator: Weijian Guo         
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Weijian Guo, MD,PhD, Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT04555369    
Other Study ID Numbers: mCRC-ctDNA FUSCC
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No