CancerPROFOUNDNCT06217900
a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）
An observational study of Cancer, run by Shanghai Weihe Medical Laboratory Co., Ltd. at 8 sites in China.
Trial summary
This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 16,666 participants
- Where
- 8 sitesChina
- Study dates
- 28 Dec 2023to 31 Mar 2027
- 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Confirmed cancers or individuals without confirmed cancer will be invited to participate in this case-control study by a designated consenting professional.
Who may be able to join
- 40-74 years old
- Clinically and/or pathologically diagnosed cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- 40-74 years old
- Without confirmed cancer diagnosis
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
Who cannot join
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) within 14 days prior to screen
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to screen
- Recipients of therapy in past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
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- Unsuitable for this trial determined by the researchers
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) within 14 days prior to screen
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to screen
- Recipients of therapy in the past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
- Unsuitable for this trial determined by the researchers
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 100083
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
The First Hospital of Jilin University
Changchun
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Liaoning Tumor Hospital & Institute
Shenyang
About this study
Official title: PROFOUND Study: Development and Validation of a Multi-cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning: a Multicenter, Prospective, Observational, Case-control Study
This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.
Read the detailed description
Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrative multi-omic analysis. Based on the comprehensive molecular profiling, a machine learning-driven model will be trained and blinded validated independent through a two-stage approach in clinically annotated individuals. Approximately 10327 cancer patients will be enrolled in this study and early-stage cancer patients will be enriched to improve the model sensitivity on distinguishing cancers with favorable prognosis. Approximately 6339 age and sex matched controls will be included in model development, which are volunteers without a cancer diagnosis after routine cancer screening tests.
- Conditions
- Cancer
- Keywords
- cell-free DNA, methylation, cancer early detection
- 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 |
|---|---|---|
| Case arm | Participants with newly diagnosed cancer of lung, breast, digestive tract, urinary tract and etc. | |
| Control arm | Participants without a cancer diagnosis after routine cancer screening tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of cfDNA methylation-based multiple cancers early detection model in case-control study
The sensitivity, specificity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.
Measured: 12 months
Secondary outcomes (3)
The performance of cfDNA methylation-based multiple cancers early detection model in early stage cancer cases
The sensitivity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting stage I to II cancer at 95% confidence interval.
Measured: 12 months
The performance of multi-omic-based multiple cancers early detection model in case-control study
The sensitivity, specificity and tissue origin accuracy of multi-omic-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.
Measured: 12 months
The performance of different multi-cancer early detection models in different subgroups
The sensitivity and specificity of cfDNA methylation-based or multi-omic-based multiple cancers early detection model in different subgroups of the population (such as age, gender, cancer pathological classification, and clinical stage) at 95% confidence interval.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start28 Dec 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Mar 2027 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16,666 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jun Wang, Principal investigator, Peking University People's HospitalXiaohui Wu, Study director, Shanghai Weihe Medical Laboratory Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217900
- Sponsor's protocol ID
- PROFOUND
- Acronym
- PROFOUND
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2023
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROFOUND Study: Development and Validation of a Multi-cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning: a Multicenter, Prospective, Observational, Case-control Study
- ClinicalTrials.gov ID
- NCT06217900
- Acronym / sponsor ID
- PROFOUND / PROFOUND
- Conditions
- Cancer
- Keywords
- cell-free DNA, methylation, cancer early detection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 16,666 participants (estimated)
- Lead sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 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 study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.
Detailed description
Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrative multi-omic analysis. Based on the comprehensive molecular profiling, a machine learning-driven model will be trained and blinded validated independent through a two-stage approach in clinically annotated individuals. Approximately 10327 cancer patients will be enrolled in this study and early-stage cancer patients will be enriched to improve the model sensitivity on distinguishing cancers with favorable prognosis. Approximately 6339 age and sex matched controls will be included in model development, which are volunteers without a cancer diagnosis after routine cancer screening tests.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case arm | – | –Participants with newly diagnosed cancer of lung, breast, digestive tract, urinary tract and etc. |
| Control arm | – | –Participants without a cancer diagnosis after routine cancer screening tests. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed cancers or individuals without confirmed cancer will be invited to participate in this case-control study by a designated consenting professional.
Key inclusion criteria (7 listed)
- 40-74 years old
- Clinically and/or pathologically diagnosed cancer
- No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
- Able to provide a written informed consent and willing to comply with all part of the protocol procedures
- 40-74 years old
Key exclusion criteria (14 listed)
- Pregnancy or lactating women
- Known prior or current diagnosis of other types of malignancies comorbidities
- Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) within 14 days prior to screen
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
- Recipients of blood transfusion within 30 days prior to screen
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
The performance of cfDNA methylation-based multiple cancers early detection model in case-control study
Time frame: 12 months
The sensitivity, specificity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.
3 secondary outcomes
The performance of cfDNA methylation-based multiple cancers early detection model in early stage cancer cases
Time frame: 12 months
The performance of multi-omic-based multiple cancers early detection model in case-control study
Time frame: 12 months
The performance of different multi-cancer early detection models in different subgroups
Time frame: 12 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 13 Oct 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. This study is not recruiting at the moment.
Jun Wang principal investigator
Peking University People's Hospital
Xiaohui Wu study director
Shanghai Weihe Medical Laboratory Co., Ltd.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Shanghai Weihe Medical Laboratory Co., Ltd. at 8 sites in China.
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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of cfDNA methylation-based multiple cancers early detection model in case-control study (time frame: 12 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 13 Oct 2026.