Colorectal CancerNCT07834268
Feasibility of Multi-cancer Early Detection Test in Screening Population (NQMD-CS)
A study testing MCED in people with Colorectal Cancer and Grastic Cancer, run by Fifth Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
Trial summary
This is a prospective, multicenter screening cohort study designed to evaluate the feasibility of a blood-based multi-cancer early detection (MCED) test in an asymptomatic screening population. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Grastic Cancer, Esophageal Cancer
- What is being tested?
- MCED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jul 2025to Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- 1.40-74 years old; 2.Able to provide a written informed consent; 3.Willing to comply with all part of the protocol procedures.
Who cannot join
- With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen;
- Have definite contraindications of cancer screening examination and diagnostic procedures;
- Unable to comply with the protocol procedures;
- Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date;
- Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrine therapy for cancer is not an exclusion criterion;
- Recipients of anti-tumor therapy within 30 days prior to screen;
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- Pregnancy or lactating women;
- Recipients of organ transplant or prior bone marrow transplant or stem cell transplant;
- Recipients of blood transfusion within 7 days prior to screen;
- With autoimmune diseases;
- Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw;
- Unsuitable for this trial determined by the researchers.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Huidong People's Hospital
Huizhou, Guangdong
About this study
Official title: NQMD-CS: A Prospective Interventional Study to Evaluate the Feasibility of a Blood-Based Multi-Cancer Early Detection Test in an Asymptomatic Screening Population
This is a prospective, multicenter screening cohort study designed to evaluate the feasibility of a blood-based multi-cancer early detection (MCED) test in an asymptomatic screening population. Eligible participants will undergo blood-based MCED testing, standard cancer screening as appropriate, and 1-year active follow-up. Participants with positive MCED results or highly suspicious findings from standard screening will undergo diagnostic evaluation to determine cancer status, enabling a more accurate assessment of the test's clinical performance.
Read the detailed description
This study consists of four stages: recruitment and enrollment, testing and screening, diagnostic evaluation, and follow-up.
Approximately 1,250 participants will be recruited through community-based recruitment and invitations from family physicians to enhance the representativeness of the screening population. Peripheral blood will be collected from each participant for blood-based multi-cancer early detection (MCED) testing, which is designed to detect signals associated with five cancer types, including lung, colorectal, liver, gastric, and esophageal cancers. Participants will also undergo usual care and standard single-cancer screening, as appropriate, based on their individual cancer risk assessment.
During the diagnostic stage, participants with positive MCED results will undergo diagnostic evaluation guided by the cancer site indicated by the MCED test. Participants with highly suspicious findings from standard screening or usual care will also undergo diagnostic evaluation according to applicable clinical guidelines. The number and types of diagnostic tests and procedures required to achieve diagnostic resolution will be recorded to assess the downstream diagnostic burden and safety of MCED.
During the follow-up stage, cancer status will be actively followed. For participants diagnosed with cancer, relevant clinical information will be collected.
In addition to the assessment of safety and performance, participant-reported outcome questionnaires will be administered at baseline, upon delivery of screening results, upon completion of the diagnostic evaluation, and at the 1-year follow-up to assess the psychological impact of MCED testing.
- Conditions
- Colorectal Cancer, Grastic Cancer, Esophageal Cancer, Lung Cancer, Liver Cancer
- Being tested
- MCED
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Lung Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCEDDiagnostic test
A cfDNA methylation-based early cancer detection model that provides a binary positive/negative result and predicts the tissue of origin when a cancer-associated signal is detected.
| Study group | Role | What they receive |
|---|---|---|
| MCED-screening | Experimental | MCED results are returned to investigators and participants. Participants with a cancer signal undergo clinician-guided diagnostic assessment to confirm or rule out cancer Receives: Diagnostic Test: MCED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MCED in the intended use setting
Descriptive statistics will be used to summarize the number of the five pre-specified cancers diagnosed by MCED.
Measured: From enrollment to the Follow-up at 1 year
Safety of MCED in the intended use setting
Descriptive statistics will be used to summarize the time to diagnostic resolution following receipt of a positive MCED result and the number and types of diagnostic tests and procedures performed during the diagnostic evaluation.
Measured: From enrollment to the Follow-up at 1 year
Secondary outcomes (4)
Performance of MCED in the intended use setting.
Positive Predictive Value defined as the proportion of participants confirmed to have the five target cancers among MCED positive individuals, compared against the clinical diagnostic gold standard.
Negative Predictive Value defined as the proportion of participants free of the five target cancers among individuals with negative MCED test results, as compared with clinical diagnosis.
Measured: From enrollment to the Follow-up at 1 year
Tissue-of-origin accuracy of MCED
Tissue-of-origin accuracy is defined as the proportion of participants with a correct tissue-of-origin prediction among those with a positive MCED test result and a confirmed cancer diagnosis.
Measured: From enrollment to the Follow-up at 1 year
Participant-reported anxiety impact
Changes in anxiety over the course of the study will be assessed using the short form of the State-Trait Anxiety Inventory (STAI). The total STAI score and changes in the score across assessment time points will be summarized using descriptive statistics.
Measured: From enrollment to the Follow-up at 1 year
Participant-reported health related quality of life (HRQoL)
Changes in HRQoL over the course of the study will be assessed using the EQ-5D-5L. The EQ-5D-5L utility value at each assessment time point and changes in the utility value over time will be summarized using descriptive statistics, with higher values indicating better health-related quality of life.
Measured: From enrollment to the Follow-up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start2 Jul 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834268
- Sponsor's protocol ID
- GYWY-L2025-102
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NQMD-CS: A Prospective Interventional Study to Evaluate the Feasibility of a Blood-Based Multi-Cancer Early Detection Test in an Asymptomatic Screening Population
- ClinicalTrials.gov ID
- NCT07834268
- Acronym / sponsor ID
- GYWY-L2025-102
- Conditions
- Colorectal Cancer, Grastic Cancer, Esophageal Cancer, Lung Cancer, Liver Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Fifth Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 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, multicenter screening cohort study designed to evaluate the feasibility of a blood-based multi-cancer early detection (MCED) test in an asymptomatic screening population. Eligible participants will undergo blood-based MCED testing, standard cancer screening as appropriate, and 1-year active follow-up. Participants with positive MCED results or highly suspicious findings from standard screening will undergo diagnostic evaluation to determine cancer status, enabling a more accurate assessment of the test's clinical performance.
Detailed description
This study consists of four stages: recruitment and enrollment, testing and screening, diagnostic evaluation, and follow-up.
Approximately 1,250 participants will be recruited through community-based recruitment and invitations from family physicians to enhance the representativeness of the screening population. Peripheral blood will be collected from each participant for blood-based multi-cancer early detection (MCED) testing, which is designed to detect signals associated with five cancer types, including lung, colorectal, liver, gastric, and esophageal cancers. Participants will also undergo usual care and standard single-cancer screening, as appropriate, based on their individual cancer risk assessment.
During the diagnostic stage, participants with positive MCED results will undergo diagnostic evaluation guided by the cancer site indicated by the MCED test. Participants with highly suspicious findings from standard screening or usual care will also undergo diagnostic evaluation according to applicable clinical guidelines. The number and types of diagnostic tests and procedures required to achieve diagnostic resolution will be recorded to assess the downstream diagnostic burden and safety of MCED.
During the follow-up stage, cancer status will be actively followed. For participants diagnosed with cancer, relevant clinical information will be collected.
In addition to the assessment of safety and performance, participant-reported outcome questionnaires will be administered at baseline, upon delivery of screening results, upon completion of the diagnostic evaluation, and at the 1-year follow-up to assess the psychological impact of MCED testing.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCED-screening | Experimental | Diagnostic Test: MCEDMCED results are returned to investigators and participants. Participants with a cancer signal undergo clinician-guided diagnostic assessment to confirm or rule out cancer |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.40-74 years old; 2.Able to provide a written informed consent; 3.Willing to comply with all part of the protocol procedures.
Key exclusion criteria (12 listed)
- With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen;
- Have definite contraindications of cancer screening examination and diagnostic procedures;
- Unable to comply with the protocol procedures;
- Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date;
- Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrine therapy for cancer is not an exclusion criterion;
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 |
|---|---|---|
| MCEDA cfDNA methylation-based early cancer detection model that provides a binary positive/negative result and predicts the tissue of origin when a cancer-associated signal is detected. | Diagnostic test | MCED-screening |
Primary outcome
Feasibility of MCED in the intended use setting
Time frame: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the number of the five pre-specified cancers diagnosed by MCED.
Safety of MCED in the intended use setting
Time frame: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the time to diagnostic resolution following receipt of a positive MCED result and the number and types of diagnostic tests and procedures performed during the diagnostic evaluation.
4 secondary outcomes
Performance of MCED in the intended use setting.
Time frame: From enrollment to the Follow-up at 1 year
Tissue-of-origin accuracy of MCED
Time frame: From enrollment to the Follow-up at 1 year
Participant-reported anxiety impact
Time frame: From enrollment to the Follow-up at 1 year
Participant-reported health related quality of life (HRQoL)
Time frame: From enrollment to the Follow-up at 1 year
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 22 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCED in people with Colorectal Cancer and Grastic Cancer, run by Fifth Affiliated Hospital of Guangzhou Medical University at 2 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 1 inclusion and 12 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Feasibility of MCED in the intended use setting (time frame: From enrollment to the Follow-up at 1 year). 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 22 Sep 2026.