Early Diagnosis of Colorectal Cancer and AdenomaNCT05204433
Correlation Between SFRP1 and Colorectal Cancer and Adenoma
An observational study of Early Diagnosis of Colorectal Cancer and Adenoma, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1_16_17_18 CpG site was good performance as a diagnostic marker of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Diagnosis of Colorectal Cancer and Adenoma
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2019to 30 Mar 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive adult patients undergoing an outpatient endoscopy
Who may be able to join
- consecutive adult patients undergoing an outpatient endoscopy and histopathologically diagnosed as colorectal cancer or adenoma. Also, healthy individuals were invited to be enrolled.
Who cannot join
- Lynch syndrome
- Familial adenomatous polyposis
- MUTYH associated polyposis
- Peutz-Jeghers syndrome
- Juvenile polyposis syndrome
- Serrated polyposis syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Methylation Site of SFRP1 Gene Promoter and Colorectal Cancer and Adenoma
In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1_16_17_18 CpG site was good performance as a diagnostic marker of colorectal cancer.
- Being tested
- no intervention
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| normal control | healthy volunteers Receives: Other: no intervention | |
| adenoma | pathologically reported colorectal adenoma Receives: Other: no intervention | |
| colorectcal cancer | pathologically reported colon cancers Receives: Other: no intervention | |
| High risk group | pathologically reported inflammatory bowel diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of methylation markers from stool samples
assess the effectiveness of methylation markers from stool samples in colon cancer patients, colorectal adenoma patients, compared with normal volunteers
Measured: 3 years
Secondary outcomes (1)
assess the capacities of RF model in screening potential clinical biomarkers.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start5 Jan 2019
- Primary completion20 Feb 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Diagnosis of Colorectal Cancer and AdenomaStudies 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
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Liang, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204433
- Sponsor's protocol ID
- XJLJ-Fecal-adenoma
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Methylation Site of SFRP1 Gene Promoter and Colorectal Cancer and Adenoma
- ClinicalTrials.gov ID
- NCT05204433
- Acronym / sponsor ID
- XJLJ-Fecal-adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 24 Jan 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.
In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1_16_17_18 CpG site was good performance as a diagnostic marker of colorectal cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal control | – | Other: no interventionhealthy volunteers |
| adenoma | – | Other: no interventionpathologically reported colorectal adenoma |
| colorectcal cancer | – | Other: no interventionpathologically reported colon cancers |
| High risk group | – | –pathologically reported inflammatory bowel diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive adult patients undergoing an outpatient endoscopy
Key inclusion criteria (1 listed)
- consecutive adult patients undergoing an outpatient endoscopy and histopathologically diagnosed as colorectal cancer or adenoma. Also, healthy individuals were invited to be enrolled.
Key exclusion criteria (6 listed)
- Lynch syndrome
- Familial adenomatous polyposis
- MUTYH associated polyposis
- Peutz-Jeghers syndrome
- Juvenile polyposis syndrome
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 |
|---|---|---|
| no interventionno intervention | Other | adenoma, colorectcal cancer, normal control |
Primary outcome
effectiveness of methylation markers from stool samples
Time frame: 3 years
assess the effectiveness of methylation markers from stool samples in colon cancer patients, colorectal adenoma patients, compared with normal volunteers
1 secondary outcome
assess the capacities of RF model in screening potential clinical biomarkers.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diagnosis of Colorectal Cancer and Adenoma, run by Xijing Hospital of Digestive Diseases 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 1 inclusion and 6 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 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of methylation markers from stool samples (time frame: 3 years). 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 Jan 2022.