Colorectal AdenomaRECOMMENDNCT05587452
Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence
An observational study of Colorectal Adenoma and Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 5 sites in China.
Trial summary
To evaluate the accuracy and effectiveness of a novel screening method based on plasma multi-omics combining with artificial intelligence in a large prospective cohort for the detection of colorectal cancer and advanced adenomas. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Cancer
- What is being tested?
- Colonoscopy, Test of ctDNA methylation and Test of characteristics of ctDNA fragment
- How many people
- 950 participants
- Where
- 5 sitesChina
- Study dates
- 1 May 2022to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Heathy group: Patients without colorectal adenoma or cancer examined by colonoscopy Precancerous group: Patients at least meet one of the following conditions: ① Diameter >10mm ② Villus-tubiform adenoma ③ More than 25% of villi structure in mixed adenoma ④High-grade intraepithelial neoplasia Colorectal cancer group: Patients diagnosed with adenocarcinoma by colonoscopy and histological examination.
Who may be able to join
- Inclusion criteria for colorectal cancer/advanced adenoma 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Be able to provide sufficient and qualified blood samples for this study 3) Patients with pathological diagnosis of colorectal cancer stage I-III (TNM staging according to AJCC 8th edition colorectal cancer staging system) 4) No previous cancer treatment, including chemotherapy, radiotherapy, targeted or immunotherapy, and any surgery treat 5) Advanced adenoma should at least meet one of the following conditions: ① Diameter >10mm ② Villus-tubiform adenoma ③ More than 25% of villi structure in mixed adenoma ④High-grade intraepithelial neoplasia
- Inclusion criteria for healthy people 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Diagnosed without colorectal adenoma or cancer by colonoscopy within 12 months
Who cannot join
- Exclusion criteria for colorectal cancer/advanced adenoma 1) Women who are pregnant or breastfeeding 2) Currently diagnosed with another cancer or have a history cancer 3) Persistent fever or receiving anti-inflammatory treatment within 14 days before blood samples are taken in this study 4) Receiving blood transfusion within 30 days 5) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 6) Digestive tract bleeding, obstruction, perforation and any trauma or surgery within 3 months 7) Poor physical condition, not suitable for extraction blood samples 8) Subjects who are judged by the investigator to be unsuitable to participate in this study for other reasons;
- Exclusion criteria for healthy people 1) Women who are pregnant or breastfeeding 2) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 3) Have a history cancer 4) Receiving blood transfusion within 30 days 5) Poor physical condition, not suitable for extraction Blood samples 6) Diagnosed with precancerous lesions by colonoscopy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jianqiang Tang, Dr., +8613661090026, doc_tjq@hotmail.com
Jianqiang Tang, Dr.
- Recruiting
Beiijing Fengtai Hospital
Beijing, Beijing Municipality
Fucheng Liu, Dr.
- Recruiting
Cangzhou Central Hospital
Cangzhou, Hebei
Guiwei Liu, Dr., +8618031792096
- Recruiting
Heji Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi
Wei Guo, Dr., +8613835513617
- Recruiting
Affiliated Hospital of Weifang Medical University
Weifang, Shandong
Bin Ren, Dr., +8613563610520
About this study
Official title: Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence-a Multi-center, Prospective Study
To evaluate the accuracy and effectiveness of a novel screening method based on plasma multi-omics combining with artificial intelligence in a large prospective cohort for the detection of colorectal cancer and advanced adenomas.
Read the detailed description
Minimally invasive detection of circulating tumor DNA (ctDNA) in peripheral blood of patients with colorectal malignancies via liquid biopsy has emerged as a promising biomarker. This is urgently needed, as conventional imaging and plasma protein-derived biomarkers lack sensitivity and specificity.The goal of this observational study is to evaluate the effectiveness and accuracy of a novel screening method based on plasma multi-omics combining with artificial intelligence in five hospitals around China for the detection of colorectal cancer and advanced adenomas.
- Conditions
- Colorectal Adenoma, Colorectal Cancer
- Being tested
- Colonoscopy, Test of ctDNA methylation, Test of characteristics of ctDNA fragment
- Keywords
- Colorectal cancer, Early screening, Multi-omics, ctDNA, Artifical intelligence
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic test
Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer
Test of ctDNA methylationDiagnostic test
A specified panel is used to detect the site of methylation of ctDNA in plasma
Test of characteristics of ctDNA fragmentDiagnostic test
Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | People without colorectal adenoma or cancer Receives: Diagnostic Test: Colonoscopy; Diagnostic Test: Test of ctDNA methylation; Diagnostic Test: Test of characteristics of ctDNA fragment | |
| Advanced adenoma group | People with colorectal adenoma Receives: Diagnostic Test: Colonoscopy; Diagnostic Test: Test of ctDNA methylation; Diagnostic Test: Test of characteristics of ctDNA fragment | |
| Colorectal cancer group | People with colorectal cancer Receives: Diagnostic Test: Colonoscopy; Diagnostic Test: Test of ctDNA methylation; Diagnostic Test: Test of characteristics of ctDNA fragment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity (for colorectal cancer and\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.
Measured: Through study completion, an average of 1 year
Specificity
Specificity (for colorectal cancer and\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 May 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cangzhou Central Hospital, Weifang Medical University, Heji Hospital affiliated to Changzhi Medical College, Beijng Fengtai Hospital
- Responsible party
- Principal investigator, Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587452
- Sponsor's protocol ID
- NCC3511
- Acronym
- RECOMMEND
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence-a Multi-center, Prospective Study
- ClinicalTrials.gov ID
- NCT05587452
- Acronym / sponsor ID
- RECOMMEND / NCC3511
- Conditions
- Colorectal Adenoma, Colorectal Cancer
- Keywords
- Colorectal cancer, Early screening, Multi-omics, ctDNA, Artifical intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Cangzhou Central Hospital, Weifang Medical University, Heji Hospital affiliated to Changzhi Medical College, Beijng Fengtai Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 Oct 2022 (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.
To evaluate the accuracy and effectiveness of a novel screening method based on plasma multi-omics combining with artificial intelligence in a large prospective cohort for the detection of colorectal cancer and advanced adenomas.
Detailed description
Minimally invasive detection of circulating tumor DNA (ctDNA) in peripheral blood of patients with colorectal malignancies via liquid biopsy has emerged as a promising biomarker. This is urgently needed, as conventional imaging and plasma protein-derived biomarkers lack sensitivity and specificity.The goal of this observational study is to evaluate the effectiveness and accuracy of a novel screening method based on plasma multi-omics combining with artificial intelligence in five hospitals around China for the detection of colorectal cancer and advanced adenomas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Diagnostic Test: Colonoscopy, Diagnostic Test: Test of ctDNA methylation, Diagnostic Test: Test of characteristics of ctDNA fragmentPeople without colorectal adenoma or cancer |
| Advanced adenoma group | – | Diagnostic Test: Colonoscopy, Diagnostic Test: Test of ctDNA methylation, Diagnostic Test: Test of characteristics of ctDNA fragmentPeople with colorectal adenoma |
| Colorectal cancer group | – | Diagnostic Test: Colonoscopy, Diagnostic Test: Test of ctDNA methylation, Diagnostic Test: Test of characteristics of ctDNA fragmentPeople with colorectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Heathy group: Patients without colorectal adenoma or cancer examined by colonoscopy Precancerous group: Patients at least meet one of the following conditions: ① Diameter >10mm ② Villus-tubiform adenoma ③ More than 25% of villi structure in mixed adenoma ④High-grade intraepithelial neoplasia Colorectal cancer group: Patients diagnosed with adenocarcinoma by colonoscopy and histological examination.
Key inclusion criteria (2 listed)
- Inclusion criteria for colorectal cancer/advanced adenoma 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Be able to provide sufficient and qualified blood samples for this study 3) Patients with pathological diagnosis of colorectal cancer stage I-III (TNM staging according to AJCC 8th edition colorectal cancer staging system) 4) No previous cancer treatment, including chemotherapy, radiotherapy, targeted or immunotherapy, and any surgery treat 5) Advanced adenoma should at least meet one of the following conditions: ① Diameter >10mm ② Villus-tubiform adenoma ③ More than 25% of villi structure in mixed adenoma ④High-grade intraepithelial neoplasia
- Inclusion criteria for healthy people 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Diagnosed without colorectal adenoma or cancer by colonoscopy within 12 months
Key exclusion criteria (2 listed)
- Exclusion criteria for colorectal cancer/advanced adenoma 1) Women who are pregnant or breastfeeding 2) Currently diagnosed with another cancer or have a history cancer 3) Persistent fever or receiving anti-inflammatory treatment within 14 days before blood samples are taken in this study 4) Receiving blood transfusion within 30 days 5) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 6) Digestive tract bleeding, obstruction, perforation and any trauma or surgery within 3 months 7) Poor physical condition, not suitable for extraction blood samples 8) Subjects who are judged by the investigator to be unsuitable to participate in this study for other reasons;
- Exclusion criteria for healthy people 1) Women who are pregnant or breastfeeding 2) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 3) Have a history cancer 4) Receiving blood transfusion within 30 days 5) Poor physical condition, not suitable for extraction Blood samples 6) Diagnosed with precancerous lesions by colonoscopy.
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 |
|---|---|---|
| ColonoscopyColonoscopy is performed to identify whether the patient has colorectal adenoma or cancer | Diagnostic test | Advanced adenoma group, Colorectal cancer group, Healthy group |
| Test of ctDNA methylationA specified panel is used to detect the site of methylation of ctDNA in plasma | Diagnostic test | Advanced adenoma group, Colorectal cancer group, Healthy group |
| Test of characteristics of ctDNA fragmentLow pass whole genome sequencing is used to detect the characteristics of ctDNA fragment | Diagnostic test | Advanced adenoma group, Colorectal cancer group, Healthy group |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 1 year
Sensitivity (for colorectal cancer and\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.
Specificity
Time frame: Through study completion, an average of 1 year
Specificity (for colorectal cancer and\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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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.
5 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 Adenoma and Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 5 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianqiang Tang, Dr. (+8613661090036, doc_tjq@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Through study completion, an average of 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 24 Oct 2022.