Colorectal CancerNCT05530746
Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC
An observational study of Colorectal Cancer and Precancerous Lesion, run by Changhai Hospital at 1 site in China.
Trial summary
Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Precancerous Lesion, Inflammatory Bowel Diseases
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 May 2023
- 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: The study population was derived from patients at the Gastroenterology Endoscopy Center of Changhai Hospital in Shanghai, China. And the subjects were divided into five groups according to clinical and histopathological characteristics.
Who may be able to join
- Patients whose age is between 18-75.
- Patients who have signed informed consent form.
Who cannot join
- Patients who have undergone colonic resection or polypectomy.
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days.
- Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
- Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- Patients with failed cecal intubation.
- Patients with poor BPQ necessitated a second bowel preparation.
- Patients refusing to participate or to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Naval Medical University
Shanghai, 200433
Yu Bai, M.D., +86-021-81873241, baiyu1998@hotmail.com
Yihang Song, M.D., +86-021-31162770, noah_ir77@163.com
About this study
Official title: Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of Colorectal Cancer
Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.
- Keywords
- multi-omics study, adenoma, Inflammatory Bowel Disease
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases, 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 |
|---|---|---|
| Control | Volunteers with no significant abnormalities on colonoscopy were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Non-advanced adenoma | Patients with non-advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Advanced adenoma | Patients with advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Inflammatory bowel disease | Patients with inflammatory bowel disease were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Colorectal cancer | Patients with colorectal cancer were given informed consent to obtain cancer tissue biopsies and fecal specimens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of advanced colorectal adenoma
An advanced colorectal adenoma is defined as a colorectal adenoma ≥10 mm, adenoma with tubulovillous or villous histology, or adenoma with high-grade dysplasia
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Detection of colorectal cancer
Lesions will be confirmed as malignant by histopathologic examination.
Measured: Through study completion, an average of 1 year
Detection of non-advanced colorectal adenoma
A non-advanced colorectal adenoma is defined as tubular adenoma less than 1cm in diameter.
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 posted7 Sep 2022
- Study start1 May 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530746
- Sponsor's protocol ID
- multi-omics
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang D, Tang Z, Huang H, Zhou G, Cui C, Weng Y, Liu W, Kim S, Lee S, Perez-Neut M, Ding J, Czyz D, Hu R, Ye Z, He M, Zheng YG, Shuman HA, Dai L, Ren B, Roeder RG, Becker L, Zhao Y. Metabolic regulation of gene expression by histone lactylation. Nature. 2019 Oct;574(7779):575-580. doi: 10.1038/s41586-019-1678-1. Epub 2019 Oct 23.
PubMed 31645732Zackular JP, Rogers MA, Ruffin MT 4th, Schloss PD. The human gut microbiome as a screening tool for colorectal cancer. Cancer Prev Res (Phila). 2014 Nov;7(11):1112-21. doi: 10.1158/1940-6207.CAPR-14-0129. Epub 2014 Aug 7.
PubMed 25104642Wang J, Liu S, Wang H, Zheng L, Zhou C, Li G, Huang R, Wang H, Li C, Fan X, Fu X, Wang X, Guo H, Guan J, Sun Y, Song X, Li Z, Mu D, Sun J, Liu X, Qi Y, Niu F, Chen C, Wu X, Wang X, Song X, Zou H. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clin Epigenetics. 2020 Oct 30;12(1):162. doi: 10.1186/s13148-020-00954-x.
PubMed 33126908
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05530746
- Acronym / sponsor ID
- multi-omics
- Keywords
- multi-omics study, adenoma, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 7 Sep 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.
Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Volunteers with no significant abnormalities on colonoscopy were given informed consent to obtain colon tissue biopsies and fecal specimens. |
| Non-advanced adenoma | – | –Patients with non-advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens. |
| Advanced adenoma | – | –Patients with advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens. |
| Inflammatory bowel disease | – | –Patients with inflammatory bowel disease were given informed consent to obtain colon tissue biopsies and fecal specimens. |
| Colorectal cancer | – | –Patients with colorectal cancer were given informed consent to obtain cancer tissue biopsies and fecal specimens. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was derived from patients at the Gastroenterology Endoscopy Center of Changhai Hospital in Shanghai, China. And the subjects were divided into five groups according to clinical and histopathological characteristics.
Key inclusion criteria (2 listed)
- Patients whose age is between 18-75.
- Patients who have signed informed consent form.
Key exclusion criteria (7 listed)
- Patients who have undergone colonic resection or polypectomy.
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days.
- Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
- Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- Patients with failed cecal intubation.
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
Detection of advanced colorectal adenoma
Time frame: Through study completion, an average of 1 year
An advanced colorectal adenoma is defined as a colorectal adenoma ≥10 mm, adenoma with tubulovillous or villous histology, or adenoma with high-grade dysplasia
2 secondary outcomes
Detection of colorectal cancer
Time frame: Through study completion, an average of 1 year
Detection of non-advanced colorectal adenoma
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 31645732Zhang D, Tang Z, Huang H, Zhou G, Cui C, Weng Y, Liu W, Kim S, Lee S, Perez-Neut M, Ding J, Czyz D, Hu R, Ye Z, He M, Zheng YG, Shuman HA, Dai L, Ren B, Roeder RG, Becker L, Zhao Y. Metabolic regulation of gene expression by histone lactylation. Nature. 2019 Oct;574(7779):575-580. doi: 10.1038/s41586-019-1678-1. Epub 2019 Oct 23.
- Background: PubMed 25104642Zackular JP, Rogers MA, Ruffin MT 4th, Schloss PD. The human gut microbiome as a screening tool for colorectal cancer. Cancer Prev Res (Phila). 2014 Nov;7(11):1112-21. doi: 10.1158/1940-6207.CAPR-14-0129. Epub 2014 Aug 7.
- Background: PubMed 33126908Wang J, Liu S, Wang H, Zheng L, Zhou C, Li G, Huang R, Wang H, Li C, Fan X, Fu X, Wang X, Guo H, Guan J, Sun Y, Song X, Li Z, Mu D, Sun J, Liu X, Qi Y, Niu F, Chen C, Wu X, Wang X, Song X, Zou H. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clin Epigenetics. 2020 Oct 30;12(1):162. doi: 10.1186/s13148-020-00954-x.
- 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.
Zhaoshen Li, M.D principal investigator
Study Principal Investigator
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 Colorectal Cancer and Precancerous Lesion, run by Changhai Hospital 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 2 inclusion and 7 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 7 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, M.D (+86-021-31161365, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of advanced colorectal adenoma (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530746, which also lists 3 linked publications.
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 7 Sep 2022; AzTrials last refreshed its copy on 1 Nov 2026.