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

NCT04704960 | Unknown

• 1 other identifier: 4-2020-1176
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Lung Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mutations related to target drug

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

Study Arms (1)

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

Interventions

Diagnostic Test: liquid biopsy OTHER

detection of tumor DNA alteration in cf-DNA

Lung metastases from colorectal cancer, local ablative therapy (surgery or radiation)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adults over 19 years of age
• those who understand research and have written consent
• cases diagnosed with lung metastases from colorectal cancer

You may not qualify if:

• pregnant women, nursing women
• those who lack the ability to voluntarily agree
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Laboratory Medicine, Yonsei University College of Medicine

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

20 mL of whole blood is collected and cell-free DNA is extracted

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Seung-Tae Lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Tae Lee

CONTACT

82-2-2228-2446; LEE.ST@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 12, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)