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

January 11, 2021 updated by: Yonsei University
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

Intervention / Treatment

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

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

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:

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

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

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

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
Time Frame: about 6 month but additional extension for patients with relapse after local treatment
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
Time Frame: about 6 month but additional extension for patients with relapse after local treatment
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

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Seung-Tae Lee, Severance Hospital

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 (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

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

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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