Colorectal CancerNCT05200611
Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Shandong University at 2 sites in China.
Trial summary
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- What is being tested?
- Fecal Immunochemical Test
- How many people
- 5,000 participants
- Where
- 2 sitesChina
- Study dates
- 4 Jan 2022to 1 Jul 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria were enrolled.
Who may be able to join
- Adults 50-75 years old
Who cannot join
- People with history of intestinal surgery;
- People with history of colorectal cancer;
- People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
- People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea;
- Pregnancy, lactation or menstrual phase;
- Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Shanghe People's Hospital
Jinan, Shandong, 250012
Hongmei Zhang
- Recruiting
The People's Hospital of Zhaoyuan City
Yantai, Shandong
Shihuan Wang, +8613562589535
About this study
Official title: Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.
Read the detailed description
Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Being tested
- Fecal Immunochemical Test
- Keywords
- Colorectal Adenoma, Occult Bleeding, Quantitative fecal immunochemical test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Immunochemical TestDiagnostic test
Participants with positive fecal immunochemical test results were further examined by colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Immunochemical Test | People in this group with positive fecal immunochemical test results were further examined by colonoscopy. Receives: Diagnostic Test: Fecal Immunochemical Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of fecal immunochemical test to detect advanced adenoma
The detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma
Measured: 6 months
Secondary outcomes (2)
The efficacy of fecal immunochemical test to detect colorectal cancer
The detection rate and positive predictive value of fecal immunochemical test to detect colorectal cancer
Measured: 6 month
The efficacy of fecal immunochemical test to detect colorectal neoplasms
The detection rate and positive predictive value of fecal immunochemical test to detect colorectal neoplasms
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start4 Jan 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (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.
- 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The People's Hospital of Zhaoyuan City, Shanghe People's Hospital
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200611
- Sponsor's protocol ID
- 2022SDU-QILU-103
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 21 Jan 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT05200611
- Acronym / sponsor ID
- 2022SDU-QILU-103
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Keywords
- Colorectal Adenoma, Occult Bleeding, Quantitative fecal immunochemical test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- The People's Hospital of Zhaoyuan City, Shanghe People's Hospital
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 21 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.
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.
Detailed description
Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Immunochemical Test | – | Diagnostic Test: Fecal Immunochemical TestPeople in this group with positive fecal immunochemical test results were further examined by colonoscopy. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria were enrolled.
Key inclusion criteria (1 listed)
- Adults 50-75 years old
Key exclusion criteria (6 listed)
- People with history of intestinal surgery;
- People with history of colorectal cancer;
- People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
- People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea;
- Pregnancy, lactation or menstrual phase;
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 |
|---|---|---|
| Fecal Immunochemical TestParticipants with positive fecal immunochemical test results were further examined by colonoscopy. | Diagnostic test | Fecal Immunochemical Test |
Primary outcome
The efficacy of fecal immunochemical test to detect advanced adenoma
Time frame: 6 months
The detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma
2 secondary outcomes
The efficacy of fecal immunochemical test to detect colorectal cancer
Time frame: 6 month
The efficacy of fecal immunochemical test to detect colorectal neoplasms
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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.
2 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 Colorectal Neoplasms, run by Shandong University at 2 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 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 21 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 2 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 Ruchen Zhou (+8615949702165, sdlwzrc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of fecal immunochemical test to detect advanced adenoma (time frame: 6 months). 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 21 Jan 2022.