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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04704960
Acronym
CANDIDATE
Enrollment
400
Registered
2021-01-12
Start date
2021-02-28
Completion date
2023-12-31
Last updated
2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Lung Metastases

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.

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.

Interventions

OTHERDiagnostic Test: liquid biopsy

detection of tumor DNA alteration in cf-DNA

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
correlation between circulating tumor DNA (ctDNA) before and after local treatment (surgery or radiation) and recurrence of lung metastases from colorectal cancerabout 6 month but additional extension for patients with relapse after local treatmentThe 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.

Secondary

MeasureTime frameDescription
mutations related to target drugabout 6 month but additional extension for patients with relapse after local treatmentThe investigations check for target drug related mutations from mutation profiling of ctDNA.

Countries

South Korea

Contacts

Primary ContactSeung-Tae Lee
LEE.ST@yuhs.ac82-2-2228-2446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026