Invasive CancerNCT06231953
A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers
An observational study of Invasive Cancer and Healthy Volunteer, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Invasive Cancer, Healthy Volunteer
- How many people
- 4,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who have diagnosed invasive cancer or healthy volunteers
Who may be able to join
- Aged 19 years or older
- Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination
- Subjects who have agreed to provide clinical information and blood samples
- Subjects who have agreed for the storage and secondary use of residual blood samples for research
- Subjects who have understood the study and are able to provide a written informed consent
Who cannot join
- Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders
- Subjects with a history of HIV, HTLV, or Syphilis infection
- Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers
- Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cancer Center, Yonsei Univ. College of Medicine
Seoul
Joohyuk Sohn, +82-2-2228-8135, oncosohn@yuhs.ac
About this study
Official title: A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers.
This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.
The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.
Read the detailed description
AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.
The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.
The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.
- Conditions
- Invasive Cancer, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Patients who have diagnosed as invasive cancers | |
| Healthy volunteers | Subjects who have done cancer screening tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value
Measured: 36 months
Accuracy of prediction for the origin of cancer, assessed by concordance rate
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start13 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joohyuk Sohn, Principal investigator, Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231953
- Sponsor's protocol ID
- 4-2022-0299
- Status last verified
- Jan 2024
- First submitted
- 18 May 2023
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT06231953
- Acronym / sponsor ID
- 4-2022-0299
- Conditions
- Invasive Cancer, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (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.
This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.
The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.
Detailed description
AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.
The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.
The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | –Patients who have diagnosed as invasive cancers |
| Healthy volunteers | – | –Subjects who have done cancer screening tests |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have diagnosed invasive cancer or healthy volunteers
Key inclusion criteria (5 listed)
- Aged 19 years or older
- Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination
- Subjects who have agreed to provide clinical information and blood samples
- Subjects who have agreed for the storage and secondary use of residual blood samples for research
- Subjects who have understood the study and are able to provide a written informed consent
Key exclusion criteria (4 listed)
- Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders
- Subjects with a history of HIV, HTLV, or Syphilis infection
- Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers
- Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value
Time frame: 36 months
Accuracy of prediction for the origin of cancer, assessed by concordance rate
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- 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.
Joohyuk Sohn principal investigator
Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
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 Invasive Cancer and Healthy Volunteer, 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joohyuk Sohn (+82-2-2228-8135, oncosohn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value (time frame: 36 months). The study lists 2 primary outcomes in all. 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 30 Jan 2024.