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

NCT ID: NCT04704960

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-28

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer Lung Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Diagnostic Test: liquid biopsy

Intervention Type OTHER

detection of tumor DNA alteration in cf-DNA

Interventions

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Diagnostic Test: liquid biopsy

detection of tumor DNA alteration in cf-DNA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seung-Tae Lee

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Department of Laboratory Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Seung-Tae Lee

Role: CONTACT

82-2-2228-2446

Facility Contacts

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Seung-Tae Lee

Role: primary

82-2-2228-2446

Other Identifiers

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4-2020-1176

Identifier Type: -

Identifier Source: org_study_id

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