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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Lung Metastases
• Intervention / Treatment: Other: Diagnostic Test: liquid biopsy

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Seung-Tae Lee; Phone Number: 82-2-2228-2446; Email: LEE.ST@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Laboratory Medicine, Yonsei University College of Medicine
    • Contact: Seung-Tae Lee; Phone Number: 82-2-2228-2446; Email: LEE.ST@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

They were diagnosed with lung metastases from colorectal cancer and are Korean. They are also treated in severance hospital during the study period.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung metastases from colorectal cancer, local ablative therapy (surgery or radiation); patients diagnosed with lung metastases from colorectal cancer and undergoing surgery or radiation for lumg metastasis	Other: Diagnostic Test: liquid biopsy; detection of tumor DNA alteration in cf-DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Seung-Tae Lee, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Lung Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: 4-2020-1176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No