Colorectal CancerCANDIDATENCT04704960
CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy
An observational study of Colorectal Cancer and Lung Metastases, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Cancer, Lung Metastases
- What is being tested?
- Diagnostic Test: liquid biopsy
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adults over 19 years of age
- those who understand research and have written consent
- cases diagnosed with lung metastases from colorectal cancer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Laboratory Medicine, Yonsei University College of Medicine
Seoul
Seung-Tae Lee, 82-2-2228-2446, LEE.ST@yuhs.ac
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer, Lung Metastases
- Being tested
- Diagnostic Test: liquid biopsy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: liquid biopsyOther
detection of tumor DNA alteration in cf-DNA
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Diagnostic Test: liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 6 month but additional extension for patients with relapse after local treatment
Secondary outcomes (1)
mutations related to target drug
The investigations check for target drug related mutations from mutation profiling of ctDNA.
Measured: about 6 month but additional extension for patients with relapse after local treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seung-Tae Lee, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704960
- Sponsor's protocol ID
- 4-2020-1176
- Acronym
- CANDIDATE
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy
- ClinicalTrials.gov ID
- NCT04704960
- Acronym / sponsor ID
- CANDIDATE / 4-2020-1176
- Conditions
- Colorectal Cancer, Lung Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung metastases from colorectal cancer, local ablative therapy (surgery or radiation) | – | Other: Diagnostic Test: liquid biopsypatients diagnosed with lung metastases from colorectal cancer and undergoing surgery or radiation for lumg metastasis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- adults over 19 years of age
- those who understand research and have written consent
- cases diagnosed with lung metastases from colorectal cancer
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: liquid biopsydetection of tumor DNA alteration in cf-DNA | Other | Lung metastases from colorectal cancer, local ablative therapy (surgery or radiation) |
Primary outcome
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.
1 secondary outcome
mutations related to target drug
Time frame: about 6 month but additional extension for patients with relapse after local treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Tae Lee principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lung Metastases, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Tae Lee (82-2-2228-2446, LEE.ST@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.