Colorectal Cancer Screening Fecal Immunochemical TestNCT04959617
Multi-center Application of Quantitative FIT Technology in Colorectal Cancer Screening
An observational study of Colorectal Cancer Screening Fecal Immunochemical Test, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening Fecal Immunochemical Test
- What is being tested?
- Quantitative Fecal Immunochemical Test (qFIT)
- Type of treatment
- Medical device
- How many people
- 500,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2019to 31 Dec 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy physical examination person over 30 years of age
Who may be able to join
- Healthy people aged 30 years and planning to undergo colonoscopy;
- No history of gastrointestinal tumor;
- No ulcerative colitis or Crohn's disease;
- No gastrointestinal hemorrhagic disease;
- No history of gastrointestinal surgery, able to understand and willing to sign informed consent.
Who cannot join
- Other serious diseases of the digestive tract, such as Crohn's disease ulcerative colitis;
- Patients with gastric and esophageal cancer and other malignant tumors;
- Unable to cooperate after communication;
- Subjects who have received radiotherapy and chemotherapy;
- Other researchers believe that they are not suitable for inclusion in this clinical trial, such as mental illness patients, critical patients, pregnant women, illiterate minors, cognitive impairment PI, students of the researcher, PI, affiliated research units of the co-investigator or employees of the sponsor, etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Yingying Yu, Dr, +8613588413860, yuyingying@zju.edu.cn
About this study
Official title: Multi-center Application Study of Quantitative FIT Technology for Colorectal Cancer Screening in Chinese Physical Examination Population
In order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for Chinese healthy population
Read the detailed description
Feces were collected for quantitative FIT test. Those with positive results were further examined by colonoscopy. By comparing with pathological results of colonoscopy, the sensitivity, specificity, positive predictive value and negative predictive value of quantitative FIT technology for the diagnosis of colorectal tumors were confirmed.
- Being tested
- Quantitative Fecal Immunochemical Test (qFIT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Fecal Immunochemical Test (qFIT)Device
The study only included quantitative FIT examination in the general physical examination population over 30 years old.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of quantitative FIT
The sensitivity of quantitative FIT application in Chinese physical examination population
Measured: 1year
Specificity of quantitative FIT
The specificity of quantitative FIT application in Chinese physical examination population
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start6 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Screening Fecal Immunochemical TestStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University, The First Hospital of Jilin University, Sino-Japanese Friendship Hospital of Jilin University, First Hospital of China Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, The Second Hospital of Hebei Medical University, The First Hospital of Hebei Medical University, Jiangsu Provincial People's Hospital, The Second Hospital of Nanjing Medical University, Jiangxi Provincial People's Hopital, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Harbin Medical University, Peking Union Medical College Hospital, Shenzhen People's Hospital, Guangdong Provincial People's Hospital, Tongji Hospital, First Affiliated Hospital of Suzhou Medical College, Chinese PLA General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Inner Mongolia Medical College, Bethune International Peace Hospital, Xinqiao Hospital of Chongqing, Renmin Hospital of Wuhan University, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959617
- Sponsor's protocol ID
- 2018-181
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Application Study of Quantitative FIT Technology for Colorectal Cancer Screening in Chinese Physical Examination Population
- ClinicalTrials.gov ID
- NCT04959617
- Acronym / sponsor ID
- 2018-181
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University, The First Hospital of Jilin University, Sino-Japanese Friendship Hospital of Jilin University, First Hospital of China Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Dalian Medical University, The Second Hospital of Hebei Medical University, The First Hospital of Hebei Medical University, Jiangsu Provincial People's Hospital, The Second Hospital of Nanjing Medical University, Jiangxi Provincial People's Hopital, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Harbin Medical University, Peking Union Medical College Hospital, Shenzhen People's Hospital, Guangdong Provincial People's Hospital, Tongji Hospital, First Affiliated Hospital of Suzhou Medical College, Chinese PLA General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Inner Mongolia Medical College, Bethune International Peace Hospital, Xinqiao Hospital of Chongqing, Renmin Hospital of Wuhan University, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Jul 2021 (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 order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for Chinese healthy population
Detailed description
Feces were collected for quantitative FIT test. Those with positive results were further examined by colonoscopy. By comparing with pathological results of colonoscopy, the sensitivity, specificity, positive predictive value and negative predictive value of quantitative FIT technology for the diagnosis of colorectal tumors were confirmed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy physical examination person over 30 years of age
Key inclusion criteria (5 listed)
- Healthy people aged 30 years and planning to undergo colonoscopy;
- No history of gastrointestinal tumor;
- No ulcerative colitis or Crohn's disease;
- No gastrointestinal hemorrhagic disease;
- No history of gastrointestinal surgery, able to understand and willing to sign informed consent.
Key exclusion criteria (5 listed)
- Other serious diseases of the digestive tract, such as Crohn's disease ulcerative colitis;
- Patients with gastric and esophageal cancer and other malignant tumors;
- Unable to cooperate after communication;
- Subjects who have received radiotherapy and chemotherapy;
- Other researchers believe that they are not suitable for inclusion in this clinical trial, such as mental illness patients, critical patients, pregnant women, illiterate minors, cognitive impairment PI, students of the researcher, PI, affiliated research units of the co-investigator or employees of the sponsor, etc
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 |
|---|---|---|
| Quantitative Fecal Immunochemical Test (qFIT)The study only included quantitative FIT examination in the general physical examination population over 30 years old. | Device | – |
Primary outcome
Sensitivity of quantitative FIT
Time frame: 1year
The sensitivity of quantitative FIT application in Chinese physical examination population
Specificity of quantitative FIT
Time frame: 1year
The specificity of quantitative FIT application in Chinese physical examination population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- 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.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
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 Screening Fecal Immunochemical Test, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 5 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 9 Nov 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of quantitative FIT (time frame: 1year). 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 9 Nov 2021.