CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy

Colorectal Cancer Clinical Trial

— CANDIDATE  

Official title:

CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04704960
• Other study ID #: 4-2020-1176
• Status: Not yet recruiting
• Start date: February 2021
• Est. completion date: December 2023

Study information

• Verified date: January 2021
• Source: Yonsei University
• Contact: Seung-Tae Lee
• Phone: 82-2-2228-2446
• Email: LEE.ST[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will detect circulating tumor DNA in blood of patients with lung metastases from colorectal cancer using NGS technology and intend to use it for predicting the outcome of local treatment (surgery or radiation) and recurrence of lung metastases.

Description:

The investigators produce customized gene target panel by selecting genes that are commonly found in colorectal cancer and metastasis from existing literature. In patients diagnosed with lung metastases from colorectal cancer, 20mL of whole blood is collected before and after local treatment (surgery or radiation) and cell-free DNA (cfDNA) is extracted from the collected blood. Thereafter, 20 mL of whole blood is additionally collected once after 3 months (±2 months) and once after 6 months (±2 months) during follow-up and cfDNA is extracted. The investigators perform sequencing from the extracted cfDNA. The investigators compare the mutations detected in cfDNA before and after local treatment and identify the trend of reducing mutations in cfDNA after local treatment. So The investigators discover biomarkers for the outcome of local treatment. The investigators also search for mutations for target drugs from mutation profiling of cfDNA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. adults over 19 years of age

2. those who understand research and have written consent

3. cases diagnosed with lung metastases from colorectal cancer

Exclusion Criteria:

1. pregnant women, nursing women

2. those who lack the ability to voluntarily agree

3. participation in other clinical trials where drugs for clinical trials are administered within the past four weeks as of the date of participation in clinical trials

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Lung Metastases
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

Other:
• Diagnostic Test: liquid biopsy
detection of tumor DNA alteration in cf-DNA

Locations

Country	Name	City	State
Korea, Republic of	Department of Laboratory Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between circulating tumor DNA (ctDNA) before and after local treatment (surgery or radiation) and recurrence of lung metastases from colorectal cancer	The investigations investigate whether ctDNA changes and f/u ctDNA fraction after local treatment (surgery or radiation) can be useful as markers to predict the outcome of local treatments.	about 6 month but additional extension for patients with relapse after local treatment
Secondary	mutations related to target drug	The investigations check for target drug related mutations from mutation profiling of ctDNA.	about 6 month but additional extension for patients with relapse after local treatment