An interventional study of MCED in Colorectal Cancer, Grastic Cancer and Esophageal Cancer, sponsored by Fifth Affiliated Hospital of Guangzhou Medical University. Active, not recruiting at 2 sites in China. Open to participants aged 40 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Fifth Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Screening
Among 1,134 studies in Colorectal Neoplasms with a site in China — 526 open to participants now, 603 under way, 67 of them phase 3. Colorectal Neoplasms · China.
Among the 1,134 studies in Colorectal Neoplasms with a site in China, this one is the 20th largest by enrollment of the 889 interventional ones that give a count, is one of 125 that started in 2025, is one of 150 with no phase, reaches primary completion later than 284 of the 602 other live ones, and was the 1,115th registered.
6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.
Browse Colorectal Neoplasms studies →526 of the 1,134 studies in Colorectal Neoplasms with a site in China are open now. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18–75
Fudan University · Sites in China
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Shanghai EpimAb Biotherapeutics Co., Ltd. · Sites in China
Ages 18–74
Nanjing Leads Biolabs Co.,Ltd · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.
This study: 40 Years to 74 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,134 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 224 · Phase 2 465 · Phase 3 147 · Phase 4 21
First in 1993; this study’s year is marked. 125 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,250 is above the median of 76 across 4,801 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 80 across the 889 interventional studies, 400 across the 243 observational. Of the 213 that completed or were terminated, 27 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
247 of 1,134 have an industry lead sponsor. The 10 most frequent:
Fifth Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Fifth Affiliated Hospital of Guangzhou Medical University has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
142 of the studies in Colorectal Neoplasms with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06008119Phase 3Shanghai Kechow Pharma, Inc.Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer | 2026-12-24 |
| NCT05171660Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityCombination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer | 2026-12-30 |
| NCT03303495Phase 3Sun Yat-sen UniversityA Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC | 2026-12-31 |
| NCT06280495Phase 3Sun Yat-sen UniversityNeoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients | 2026-12-31 |
| NCT05086614Phase 3Fudan UniversityThymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer | 2027-03-31 |
Add all 142 to your calendar (.ics) → With an account.
Among the 1,134 studies in Colorectal Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1.40-74 years old; 2.Able to provide a written ; 3.Willing to comply with all part of the protocol procedures.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MCED results are returned to investigators and participants. Participants with a cancer signal undergo clinician-guided diagnostic assessment to confirm or rule out cancer
Diagnostic Test: MCED
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.
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.
Time frame: 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.
Time frame: From enrollment to the Follow-up at 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the Follow-up at 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Oct 2026, 15 months after the start.
Of 899 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 15 months is below that.
Counting every sponsor, half of 956 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fifth Affiliated Hospital of Guangzhou Medical University