CancerNCT07598747
Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects
An observational study of Cancer and Healthy Participants, run by Chang Gon Kim 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. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Healthy Participants
- How many people
- 6,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Oct 2024to 13 Oct 2032
- 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: Cancer patients 5,000, Healthy volunteers: 1,000
Who may be able to join
- Adults aged 19 years or older
- Individuals who understand the study and voluntarily provide informed consent.
- (only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who:
- Have a histologically confirmed diagnosis (including bone marrow biopsy), or
- Are highly suspected of having cancer based on clinical and/or radiologic evaluation and are scheduled for surgical resection after blood collection; and
- Have not yet initiated any treatment (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, surgical resection, etc.).
- (only for non-cancer participants) Individuals with no prior history of cancer.
- (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.
Who cannot join
- Pregnancy (self-reported pregnancy status).
- Individuals for whom blood collection is deemed difficult by the investigator.
- Individuals with a history of infection with HIV, HTLV, or syphilis.
- (only for non-cancer participants) Individuals diagnosed with another malignancy within the past 5 years (exceptions: non-melanoma skin cancer, in-situ malignancies, thyroid cancer, and cervical intraepithelial neoplasia treated with curative intent).
- (only for non-cancer participants) Individuals with cancer of unknown primary origin.
- (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.
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
Seoul, 03722
About this study
This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an artificial intelligence platform capable of detecting various types of cancer at an early stage, and evaluate its performance.
Read the detailed description
Written informed consent will be obtained from each participant, and screening will begin after obtaining consent according to the study's inclusion and exclusion criteria.
The informed consent form (ICF) approved by each institution's IRB/EC must be used, and a copy of the signed ICF will be provided to the participant.
For participants who meet the eligibility criteria (meeting all inclusion criteria and none of the exclusion criteria), 20 mL of peripheral whole blood will be collected via standard venipuncture; the time of blood collection will be considered the time of study enrollment.
The collected 20 mL of blood will be divided into two Streck tubes (approximately 10 mL per tube) and must be handled, stored, and submitted according to the most recent laboratory manual.
Cancer participants: Blood will be collected before initiation of any treatment (surgery, chemotherapy, etc.) following cancer diagnosis.
Non-cancer participants: Blood will be collected during routine health examinations.
For domestic (Korean) cases, collected specimens should be stored at room temperature and transported as whole blood (without centrifugation) to the location designated by the sponsor by the following day after collection.
Clinical data of participants (cancer patients and healthy adults)-including sex, age, race, medical history, laboratory tests, imaging, and pathology results-will be collected in the electronic case report form (eCRF).
- Conditions
- Cancer, Healthy Participants
- Medical subject headings
- Neoplasms
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 | Not described | |
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test.
Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated to evaluate its diagnostic performance for cancer detection. Sensitivity is defined as the proportion of participants with cancer who test positive on the MCED assay, while specificity is defined as the proportion of participants without cancer who test negative. Positive predictive value and negative predictive value will be calculated based on the proportion of true-positive and true-negative results among all positive and negative test results, respectively.
Measured: Assessed up to 36 months
Secondary outcomes (2)
To evaluate the accuracy of tumor of origin prediction of MCED test.
To assess whether tumor of origin predictions from the MCED test are concordant with clinically diagnosed tumor types. The numbers of concordant and discordant cases will be summarized to evaluate prediction accuracy.
Measured: Assessed up to 36 months
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test by stage.
Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated according to cancer stage to evaluate stage-specific diagnostic performance.
Measured: Assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start14 Oct 2024
- Primary completion13 Oct 2029 (estimated)
- Study completion13 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gon Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang Gon Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598747
- Sponsor's protocol ID
- 4-2024-1061
- Status last verified
- May 2026
- First submitted
- 20 Nov 2025
- Last updated
- 20 May 2026
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects
- ClinicalTrials.gov ID
- NCT07598747
- Acronym / sponsor ID
- 4-2024-1061
- Conditions
- Cancer, Healthy Participants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Chang Gon KimUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 13 Oct 2029 (estimated)
- Study completion
- 13 Oct 2032 (estimated)
- First posted
- 20 May 2026 (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. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an artificial intelligence platform capable of detecting various types of cancer at an early stage, and evaluate its performance.
Detailed description
Written informed consent will be obtained from each participant, and screening will begin after obtaining consent according to the study's inclusion and exclusion criteria.
The informed consent form (ICF) approved by each institution's IRB/EC must be used, and a copy of the signed ICF will be provided to the participant.
For participants who meet the eligibility criteria (meeting all inclusion criteria and none of the exclusion criteria), 20 mL of peripheral whole blood will be collected via standard venipuncture; the time of blood collection will be considered the time of study enrollment.
The collected 20 mL of blood will be divided into two Streck tubes (approximately 10 mL per tube) and must be handled, stored, and submitted according to the most recent laboratory manual.
Cancer participants: Blood will be collected before initiation of any treatment (surgery, chemotherapy, etc.) following cancer diagnosis.
Non-cancer participants: Blood will be collected during routine health examinations.
For domestic (Korean) cases, collected specimens should be stored at room temperature and transported as whole blood (without centrifugation) to the location designated by the sponsor by the following day after collection.
Clinical data of participants (cancer patients and healthy adults)-including sex, age, race, medical history, laboratory tests, imaging, and pathology results-will be collected in the electronic case report form (eCRF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | – |
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients 5,000, Healthy volunteers: 1,000
Key inclusion criteria (8 listed)
- Adults aged 19 years or older
- Individuals who understand the study and voluntarily provide informed consent.
- (only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who:
- (only for non-cancer participants) Individuals with no prior history of cancer.
- (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.
Key exclusion criteria (6 listed)
- Pregnancy (self-reported pregnancy status).
- Individuals for whom blood collection is deemed difficult by the investigator.
- Individuals with a history of infection with HIV, HTLV, or syphilis.
- (only for non-cancer participants) Individuals diagnosed with another malignancy within the past 5 years (exceptions: non-melanoma skin cancer, in-situ malignancies, thyroid cancer, and cervical intraepithelial neoplasia treated with curative intent).
- (only for non-cancer participants) Individuals with cancer of unknown primary origin.
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
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test.
Time frame: Assessed up to 36 months
Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated to evaluate its diagnostic performance for cancer detection. Sensitivity is defined as the proportion of participants with cancer who test positive on the MCED assay, while specificity is defined as the proportion of participants without cancer who test negative. Positive predictive value and negative predictive value will be calculated based on the proportion of true-positive and true-negative results among all positive and negative test results, respectively.
2 secondary outcomes
To evaluate the accuracy of tumor of origin prediction of MCED test.
Time frame: Assessed up to 36 months
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test by stage.
Time frame: Assessed up to 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 20 May 2026.
- 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.
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 Cancer and Healthy Participants, run by Chang Gon Kim 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 8 inclusion and 6 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 20 May 2026. 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 Chang Gon Kim (+82-2-2228-8130, inspector@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test. (time frame: Assessed up to 36 months). 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 20 May 2026.