The Value of ctDNA on Chemotherapy Efficacy for mCRC

Circulating Tumor DNA Clinical Trial

Official title:

Study on the Efficacy of Chemotherapy for Metastatic Colorectal Cancer Evaluated by Circulating Tumor DNA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04555369
• Other study ID #: mCRC-ctDNA FUSCC
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2020
• Source: Fudan University
• Contact: Weijian Guo, phD
• Phone: 8621-64175590
• Email: iamchangjinjia[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor DNA

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	the response rate predicted by ct-DNA	2 months
Secondary	Progression free survival		2 months
Secondary	Overall survival		2 months