Colorectal CancerNCT06220617
Multi-omics Study for Early Detection of Colorectal Cancer (MOED-CRC)
An observational study of Colorectal Cancer and Adenomatous Polyps, run by Zhejiang University at 6 sites in China.
Trial summary
The primary objective of the study is to screen multi-omics markers in blood samples and construct a prediction model for CRC based on liquid biopsy, and we will further optimize the prediction model by validating its clinical performance externally. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenomatous Polyps, Adenoma
- How many people
- 3,600 participants
- Where
- 6 sitesChina
- Study dates
- 11 Jan 2024to 30 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Case arm: patients with colorectal cancer or advanced adenoma. Control arm: healthy participants who have general risk or high risk of colorectal cancer
Who may be able to join
- Aged over 18 years.
- Participants confirmed with colorectal adenocarcinoma or advanced adenoma through colonoscopy and pathological examination.
- Provision of informed consent prior to any study specific procedures, sampling, and analyses.
- Individuals of "General risk arm" should meet all the following criteria:
- No history of colorectal adenomas or sessile serrated polyps.
- No history of inflammatory bowel disease (8-10 years ).
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- No family history (first-degree relatives) of colorectal cancer.
- Individuals of "High-risk arm" should meet at least one of the following criteria:
- Asia-Pacific Colorectal Screening (APC) score ≥ 3.
- Family history (first-degree relatives) of colorectal cancer.
- History of positive fecal occult blood test.
- Any 2 of the following: chronic diarrhea, chronic constipation, mucous bloody stools, history of psychological stimulation, history of chronic appendicitis or appendectomy, history of chronic biliary disease or cholecystectomy.
- Individuals with inflammatory bowel disease.
- All participants must be confirmed not to have colorectal malignancy or advanced adenomas through colonoscopy.
- Provision of informed consent prior to any study specific procedures, sampling, and analyses.
Who cannot join
- History of other malignant tumors (excluding non-melanoma skin cancer).
- Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
- Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.).
- Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
- Prior blood transfusion (including blood components) within the past 2 weeks.
- Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.
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- Pregnancy women.
- Prior or current anti-infection treatment within 14 days before blood collection.
- Inability to comply with study procedures such as blood collection and related examinations.
- Deemed unsuitable for participation in the clinical trial by the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Sun Yat-Sen University Cancer Hospital
Guangzhou
Junzhong Lin, MD
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 31000
Kefeng Ding, MD, 86-571-87784827, dingkefeng@zju.edu.cn
Kefeng Ding, MD
- Recruiting
Yunnan cancer hospital
Kunming
Yunfeng Li, MD
- Recruiting
Jiangsu province hospital
Nanjing
Yanhong Gu, MD
- Recruiting
The first affiliated hospital of Xi'an Jiaotong University
Xi'an
Xuejun Sun, MD
- Recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou
Jing Zhuang, MD
About this study
Official title: Multi-omics Study for Early Detection of Colorectal Cancer Based on Liquid Biopsy Technology
The primary objective of the study is to screen multi-omics markers in blood samples and construct a prediction model for CRC based on liquid biopsy, and we will further optimize the prediction model by validating its clinical performance externally.
Read the detailed description
This multicenter research intends to enroll 3,600 participants according to predefined inclusion and exclusion criteria. The study will be divided into two groups: the "cancer arm" and the "control arm", with the "control arm" further subdivided into the "general-risk arm" and the "high-risk arm". All participants enrolled in this study will be required to provide a 10 ml whole blood sample.
This study consists of two sections. The first section involves constructing an diagnostic prediction model for early CRC detection, and the second section focuses on validating and optimizing this prediction model.
In the first section, a prediction model for the early detection of CRC will be developed with a cohort of 1,700 participants. This cohort comprises 900 individuals in the cancer arm, including 800 CRC patients and 100 with advanced adenoma (AA), along with 800 individuals in the control rm. All participants will be required to provide a 10 ml blood sample. Cell-free DNA (cfDNA) and microRNA (miRNA) will be sequenced and analyzed with the next-generation sequencing (NGS) platform,. And cancer specific markers will be identified to construct an early detection liquid biopsy prediction model by leveraging machine learning techniques and incorporating clinical pathological diagnostic information.
In the second section, a total of 1,900 participants were include, with 1,100 in the "cancer arm" (800 CRC and 300 AA patients) and 800 in the "control arm", the prediction model established in the first section will be validated in an external cohort, and algorithm optimization will be performed.
- Conditions
- Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma
- Keywords
- Colorectal Cancer, Colorectal Neoplasms, Adenomatous Polyps, Adenoma, Advanced adenoma
- Medical subject headings
- Colorectal Neoplasms, Adenomatous Polyps, Adenoma
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 | Prospective enrollment of participants confirmed with colorectal adenocarcinoma or advanced adenoma | |
| Control arm | Prospective enrollment of healthy participants who have general risk or high risk of colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the screening test with comparison to colonoscopy
Cancer specific markers will be identified to construct an early detection liquid biopsy prediction model, which will be compared with diagnostic colonoscopy.
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start11 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (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.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- New Horizon Health Technology Co., Ltd
- Responsible party
- Principal investigator, Ding Ke-Feng, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Kefeng Ding, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220617
- Sponsor's protocol ID
- MOED-CRC
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Study for Early Detection of Colorectal Cancer Based on Liquid Biopsy Technology
- ClinicalTrials.gov ID
- NCT06220617
- Acronym / sponsor ID
- MOED-CRC
- Conditions
- Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma
- Keywords
- Colorectal Cancer, Colorectal Neoplasms, Adenomatous Polyps, Adenoma, Advanced adenoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- New Horizon Health Technology Co., Ltd
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 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.
The primary objective of the study is to screen multi-omics markers in blood samples and construct a prediction model for CRC based on liquid biopsy, and we will further optimize the prediction model by validating its clinical performance externally.
Detailed description
This multicenter research intends to enroll 3,600 participants according to predefined inclusion and exclusion criteria. The study will be divided into two groups: the "cancer arm" and the "control arm", with the "control arm" further subdivided into the "general-risk arm" and the "high-risk arm". All participants enrolled in this study will be required to provide a 10 ml whole blood sample.
This study consists of two sections. The first section involves constructing an diagnostic prediction model for early CRC detection, and the second section focuses on validating and optimizing this prediction model.
In the first section, a prediction model for the early detection of CRC will be developed with a cohort of 1,700 participants. This cohort comprises 900 individuals in the cancer arm, including 800 CRC patients and 100 with advanced adenoma (AA), along with 800 individuals in the control rm. All participants will be required to provide a 10 ml blood sample. Cell-free DNA (cfDNA) and microRNA (miRNA) will be sequenced and analyzed with the next-generation sequencing (NGS) platform,. And cancer specific markers will be identified to construct an early detection liquid biopsy prediction model by leveraging machine learning techniques and incorporating clinical pathological diagnostic information.
In the second section, a total of 1,900 participants were include, with 1,100 in the "cancer arm" (800 CRC and 300 AA patients) and 800 in the "control arm", the prediction model established in the first section will be validated in an external cohort, and algorithm optimization will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case arm | – | –Prospective enrollment of participants confirmed with colorectal adenocarcinoma or advanced adenoma |
| Control arm | – | –Prospective enrollment of healthy participants who have general risk or high risk of colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case arm: patients with colorectal cancer or advanced adenoma. Control arm: healthy participants who have general risk or high risk of colorectal cancer
Key inclusion criteria (15 listed)
- Aged over 18 years.
- Participants confirmed with colorectal adenocarcinoma or advanced adenoma through colonoscopy and pathological examination.
- Provision of informed consent prior to any study specific procedures, sampling, and analyses.
- Individuals of "General risk arm" should meet all the following criteria:
- Individuals of "High-risk arm" should meet at least one of the following criteria:
Key exclusion criteria (10 listed)
- History of other malignant tumors (excluding non-melanoma skin cancer).
- Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
- Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.).
- Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
- Prior blood transfusion (including blood components) within the past 2 weeks.
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 and specificity of the screening test with comparison to colonoscopy
Time frame: Through study completion, an average of 3 year
Cancer specific markers will be identified to construct an early detection liquid biopsy prediction model, which will be compared with diagnostic colonoscopy.
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 30 Jan 2024.
- 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.
Kefeng Ding, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Adenomatous Polyps, run by Zhejiang University at 6 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 15 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Contact Kefeng Ding, MD (86-571-87784827, dingkefeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the screening test with comparison to colonoscopy (time frame: Through study completion, an average of 3 year). 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 30 Jan 2024.