Early Detection of CancerNCT07106424
Early Screening Cohort Study of Multiple Gastrointestinal Tumors
An observational study of Early Detection of Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Gastrointestinal tumors, including esophageal cancer, gastric cancer, and colorectal cancer, are among the most common and highly prevalent malignant tumors in Shandong Province. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Early Detection of Cancer
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 10 Sep 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals undergoing screening for esophageal cancer, gastric cancer, and colorectal cancer within the Shandong Province gastrointestinal screening cohort aged 40-74 years.
Who may be able to join
- gastrointestinal cancer screening population
- age 40-75
- no prior history of tumors
Who cannot join
- Severe heart disease, heart failure;
- Severe respiratory disease, dyspnea, continuous asthma, or those with serious brain diseases;
- Severe spinal deformity, or patients with aneurysms;
- Physically weak and unable to tolerate endoscopy, or those who have difficulty remaining calm and self-controlled;
- Acute corrosive inflammation of the gastrointestinal tract, or those suspected of having a gastrointestinal perforation;
- Large amounts of ascites, severe abdominal distension, or severe esophageal varices;
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- Those with a tendency to bleed (abnormal coagulation function), or those taking anticoagulant medications. The latter must discontinue the medication for one week and have normal coagulation function before undergoing endoscopy;
- Pregnant women;
- Those with a history of iodine allergy, etc.
- Patients who have been diagnosed with tumors or have a history of prior tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
About this study
Official title: Liquid Biopsy for Early Screening Cohort Study of Multiple Gastrointestinal Tumors
Gastrointestinal tumors, including esophageal cancer, gastric cancer, and colorectal cancer, are among the most common and highly prevalent malignant tumors in Shandong Province. Currently, most patients seek medical attention only after clinical symptoms appear, by which time the disease has already reached an intermediate or advanced stage. This leads to increased treatment costs and poorer therapeutic outcomes. Early detection and intervention through screening are effective measures to improve the cure rate of gastrointestinal tumors and reduce their incidence and mortality rates.
This project leverages the Shandong Province Tumor Screening and Early Diagnosis \& Treatment Platform and is based on the ongoing Shandong Gastrointestinal Cancer Screening Cohort. It aims to collect 4,000 plasma samples from individuals undergoing simultaneous screening for esophageal, gastric, and colorectal cancers. Using Nanjing Shihe Medical Laboratory's independently developed multi-cancer early detection liquid biopsy product for gastrointestinal cancers, the study will further validate the performance of liquid biopsy in multi-cancer screening by correlating results with endoscopic findings (gastroscopy and colonoscopy).
Read the detailed description
Esophageal cancer, gastric cancer, and colorectal cancer are common gastrointestinal malignancies in China, accounting for 25.54% of all cancer cases and 33.93% of cancer-related deaths nationwide. Early detection, diagnosis, and treatment of these cancers have proven to be effective strategies for cancer prevention and control, serving as key measures to reduce mortality rates and improve survival outcomes.
Gastrointestinal tumors are also highly prevalent in our province. According to the 2022 Shandong Provincial Tumor Registry Annual Report, approximately 27,000 new cases of upper gastrointestinal cancers (including esophageal and gastric cancers) and colorectal cancer were recorded in registered areas, representing 24.71% of all malignant tumor cases. Deaths from these cancers reached about 16,300, accounting for 24.11% of all cancer-related deaths.
In recent years, with support from national public health funding, the Shandong Cancer Center has organized screening programs across the province, completing over 600,000 screenings for upper gastrointestinal and colorectal cancers. These efforts have detected more than 13,000 cases of precancerous or early-stage lesions, with a positive detection rate of 2.23%. Among these, 10,500 cases were diagnosed at an early stage, achieving an early diagnosis rate exceeding 80%, demonstrating significant societal benefits. Regions such as Feicheng, Linqu, and Dongping have established early diagnosis and treatment centers for upper gastrointestinal cancers, enabling comprehensive full-cycle management from screening to treatment and follow-up. This progress lays a crucial foundation for large-scale, long-term cohort studies.
This research is based on the ongoing Shandong Gastrointestinal Cancer Screening Cohort and will collect plasma samples from 4,000 individuals undergoing simultaneous screening for esophageal, gastric, and colorectal cancers. The study will utilize an independently developed multi-cancer early detection (MCED) liquid biopsy technology for performance validation.
- Conditions
- Early Detection of Cancer
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 |
|---|---|---|
| gastrointestinal tumor screening | They will undergo cancer screening based on liquid biopsy as well as routine gastrointestinal endoscopy screening simultaneously. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for detection of high-grade (or above) gastric/esophageal/colorectal cancer
Primary Objective:
Sensitivity for detecting high-grade or above gastric/esophageal/colorectal lesions.
Secondary Objectives:
Positive predictive value (PPV), specificity, and negative predictive value (NPV) for detecting high-grade or above gastric/esophageal/colorectal lesions.
PPV and sensitivity for detecting other cancer types.
Measured: 2024.7-2027.7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 Sep 2024
- Primary completion10 Sep 2028 (estimated)
- Study completion10 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Detection of 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106424
- Sponsor's protocol ID
- DECIPHER-GASTRO
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing plan is pending final approval by the institutional review board (IRB) and sponsor. A decision will be made prior to manuscript submission to journals
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy for Early Screening Cohort Study of Multiple Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT07106424
- Acronym / sponsor ID
- DECIPHER-GASTRO
- Conditions
- Early Detection of Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 10 Sep 2028 (estimated)
- Study completion
- 10 Sep 2030 (estimated)
- First posted
- 6 Aug 2025 (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.
Gastrointestinal tumors, including esophageal cancer, gastric cancer, and colorectal cancer, are among the most common and highly prevalent malignant tumors in Shandong Province. Currently, most patients seek medical attention only after clinical symptoms appear, by which time the disease has already reached an intermediate or advanced stage. This leads to increased treatment costs and poorer therapeutic outcomes. Early detection and intervention through screening are effective measures to improve the cure rate of gastrointestinal tumors and reduce their incidence and mortality rates.
This project leverages the Shandong Province Tumor Screening and Early Diagnosis \& Treatment Platform and is based on the ongoing Shandong Gastrointestinal Cancer Screening Cohort. It aims to collect 4,000 plasma samples from individuals undergoing simultaneous screening for esophageal, gastric, and colorectal cancers. Using Nanjing Shihe Medical Laboratory's independently developed multi-cancer early detection liquid biopsy product for gastrointestinal cancers, the study will further validate the performance of liquid biopsy in multi-cancer screening by correlating results with endoscopic findings (gastroscopy and colonoscopy).
Detailed description
Esophageal cancer, gastric cancer, and colorectal cancer are common gastrointestinal malignancies in China, accounting for 25.54% of all cancer cases and 33.93% of cancer-related deaths nationwide. Early detection, diagnosis, and treatment of these cancers have proven to be effective strategies for cancer prevention and control, serving as key measures to reduce mortality rates and improve survival outcomes.
Gastrointestinal tumors are also highly prevalent in our province. According to the 2022 Shandong Provincial Tumor Registry Annual Report, approximately 27,000 new cases of upper gastrointestinal cancers (including esophageal and gastric cancers) and colorectal cancer were recorded in registered areas, representing 24.71% of all malignant tumor cases. Deaths from these cancers reached about 16,300, accounting for 24.11% of all cancer-related deaths.
In recent years, with support from national public health funding, the Shandong Cancer Center has organized screening programs across the province, completing over 600,000 screenings for upper gastrointestinal and colorectal cancers. These efforts have detected more than 13,000 cases of precancerous or early-stage lesions, with a positive detection rate of 2.23%. Among these, 10,500 cases were diagnosed at an early stage, achieving an early diagnosis rate exceeding 80%, demonstrating significant societal benefits. Regions such as Feicheng, Linqu, and Dongping have established early diagnosis and treatment centers for upper gastrointestinal cancers, enabling comprehensive full-cycle management from screening to treatment and follow-up. This progress lays a crucial foundation for large-scale, long-term cohort studies.
This research is based on the ongoing Shandong Gastrointestinal Cancer Screening Cohort and will collect plasma samples from 4,000 individuals undergoing simultaneous screening for esophageal, gastric, and colorectal cancers. The study will utilize an independently developed multi-cancer early detection (MCED) liquid biopsy technology for performance validation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastrointestinal tumor screening | – | –They will undergo cancer screening based on liquid biopsy as well as routine gastrointestinal endoscopy screening simultaneously. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals undergoing screening for esophageal cancer, gastric cancer, and colorectal cancer within the Shandong Province gastrointestinal screening cohort aged 40-74 years.
Key inclusion criteria (3 listed)
- gastrointestinal cancer screening population
- age 40-75
- no prior history of tumors
Key exclusion criteria (10 listed)
- Severe heart disease, heart failure;
- Severe respiratory disease, dyspnea, continuous asthma, or those with serious brain diseases;
- Severe spinal deformity, or patients with aneurysms;
- Physically weak and unable to tolerate endoscopy, or those who have difficulty remaining calm and self-controlled;
- Acute corrosive inflammation of the gastrointestinal tract, or those suspected of having a gastrointestinal perforation;
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
Sensitivity for detection of high-grade (or above) gastric/esophageal/colorectal cancer
Time frame: 2024.7-2027.7
Primary Objective: Sensitivity for detecting high-grade or above gastric/esophageal/colorectal lesions. Secondary Objectives: Positive predictive value (PPV), specificity, and negative predictive value (NPV) for detecting high-grade or above gastric/esophageal/colorectal lesions. PPV and sensitivity for detecting other cancer types.
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 6 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The data sharing plan is pending final approval by the institutional review board (IRB) and sponsor. A decision will be made prior to manuscript submission to journals
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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 Early Detection of Cancer, run by Shandong Cancer Hospital and Institute at 1 site 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 3 inclusion and 10 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 6 Aug 2025. 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 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?
Contact Jinming Yu (0531-67626929, sdzlllh803@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for detection of high-grade (or above) gastric/esophageal/colorectal cancer (time frame: 2024.7-2027.7). 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 6 Aug 2025.