Polyp, ColonicNCT04444947
Influencing Factors in Patients With Colorectal and Gastric Polyps a Retrospective Study
An observational study of Polyp, Colonic, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The identification of risk factors of colorectal/gastric polyp is more helpful for preventing colorectal cancer. And modifiable factors (such as high-fat diet, abnormal blood lipid, smoking, lack of exercise, obesity), and unmodifiable factors (including age, gender, race, familial adenomas, genetic)) can affect the… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyp, Colonic
- How many people
- 64,889 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2019to 1 Jun 2020
- How long will I take part?
- 1 Year
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 43,104, patients (n=21939) with polyps and patients without polyps (n=21165) is included in this study.
Who may be able to join
- patients who underwent colonoscopies
Who cannot join
- (1) Patients with Crohn's disease, inflammatory bowel disease, and colorectal cancer; (2) Patients with ulcerative bowel disease, and intestinal tuberculosis; (3) Patients with history of familial polyposis; (4) All patients without complete endoscopic reports and complete demographics records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influencing Factors in Patients With Colorectal and Gastric a Retrospective Study
The identification of risk factors of colorectal/gastric polyp is more helpful for preventing colorectal cancer. And modifiable factors (such as high-fat diet, abnormal blood lipid, smoking, lack of exercise, obesity), and unmodifiable factors (including age, gender, race, familial adenomas, genetic)) can affect the risk of polyps. Thus early studying risk factors are the key to improving prognosis. what's more, early detection and timely treatment have important clinical significance for preventing and reducing the occurrence of gastrointestinal cancer.
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer in the world. what's more, CRC is therefore an important public health concern in China due to its rising incidence and prevalence, in addition to the burden of disease. There is robust evidence indicating that early detection by screening and removal of cancer precursor lesions offers an effective method of reducing colorectal cancer morbidity and mortality. Studies have shown that colorectal polyps are considered to be related to colorectal cancer, especially adenoma .The primary aim of this study was to identify high risk features of multiple polyps based on size, location and histological type. Patient age and gender were also characterized on the basis of a contingency analysis of a large series of Chinese patients with colorectal polyps. These data provide important information on risk factors associated with multiple polyps, which will serve as evidence for an individualized approach to colonoscopy screening guidelines in China.
Similarly, recent years, with the widespread use of gastroscopy, people's health awareness and lifestyle changes, more and more people have performed gastroscopy, so a large number of patients with gastric polyps can be found in the clinic. Gastric polyps are raised lesions that originate in the mucosal layer or submucosa and protrude into the stomach cavity. According to their pathological characteristics, they can be divided into two categories: mucosal layer and non-mucosal layer.Gastric polyps originating from mucosal layers, represented by natural, fundus glandular and adenomatous polyps, are the most common in clinical practice, while non-mucosal polyps including gastric stromal tumors and inflammatory fibrous polyps are more common in clinical practice. Although the incidence of gastric polyps is far less than that of intestinal polyps, some pathological types, especially adenomatous polyps, have obvious malignant potential and are recognized as precancerous lesions .
Therefore, we retrospectively analyzed the records of patients with gastrointestinal polyps in our hospital in the past years, and provided epidemiological data to study the factors in polyps.
- Conditions
- Polyp, Colonic
- Medical subject headings
- Colonic Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Influencing factors in patients with colorectal polyps: a retrospective study
risk factors
Measured: JUNE 30,2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start20 Feb 2019
- Primary completion30 Mar 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polyp, ColonicStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 64,889 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yue WANG, master, Principal investigator, the Human Ethics Committee of Jiangsu Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444947
- Sponsor's protocol ID
- 2019-SR-340
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Han X, Qian W, Liu Y, Zheng T, Su XJ, Zhang PP, Chen Y, Hu LH, Li ZS. Effects of age, sex and pathological type on the risk of multiple polyps: A Chinese teaching hospital study. J Dig Dis. 2020 Sep;21(9):505-511. doi: 10.1111/1751-2980.12863.
PubMed 32279448Song M, Emilsson L, Bozorg SR, Nguyen LH, Joshi AD, Staller K, Nayor J, Chan AT, Ludvigsson JF. Risk of colorectal cancer incidence and mortality after polypectomy: a Swedish record-linkage study. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):537-547. doi: 10.1016/S2468-1253(20)30009-1. Epub 2020 Mar 17.
PubMed 32192628Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12.
PubMed 21228314Oines M, Helsingen LM, Bretthauer M, Emilsson L. Epidemiology and risk factors of colorectal polyps. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):419-424. doi: 10.1016/j.bpg.2017.06.004. Epub 2017 Jun 28.
PubMed 28842051
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors in Patients With Colorectal and Gastric a Retrospective Study
- ClinicalTrials.gov ID
- NCT04444947
- Acronym / sponsor ID
- 2019-SR-340
- Conditions
- Polyp, Colonic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64,889 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 24 Jun 2020 (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.
The identification of risk factors of colorectal/gastric polyp is more helpful for preventing colorectal cancer. And modifiable factors (such as high-fat diet, abnormal blood lipid, smoking, lack of exercise, obesity), and unmodifiable factors (including age, gender, race, familial adenomas, genetic)) can affect the risk of polyps. Thus early studying risk factors are the key to improving prognosis. what's more, early detection and timely treatment have important clinical significance for preventing and reducing the occurrence of gastrointestinal cancer.
Detailed description
Colorectal cancer (CRC) is the third most common cancer in the world. what's more, CRC is therefore an important public health concern in China due to its rising incidence and prevalence, in addition to the burden of disease. There is robust evidence indicating that early detection by screening and removal of cancer precursor lesions offers an effective method of reducing colorectal cancer morbidity and mortality. Studies have shown that colorectal polyps are considered to be related to colorectal cancer, especially adenoma .The primary aim of this study was to identify high risk features of multiple polyps based on size, location and histological type. Patient age and gender were also characterized on the basis of a contingency analysis of a large series of Chinese patients with colorectal polyps. These data provide important information on risk factors associated with multiple polyps, which will serve as evidence for an individualized approach to colonoscopy screening guidelines in China.
Similarly, recent years, with the widespread use of gastroscopy, people's health awareness and lifestyle changes, more and more people have performed gastroscopy, so a large number of patients with gastric polyps can be found in the clinic. Gastric polyps are raised lesions that originate in the mucosal layer or submucosa and protrude into the stomach cavity. According to their pathological characteristics, they can be divided into two categories: mucosal layer and non-mucosal layer.Gastric polyps originating from mucosal layers, represented by natural, fundus glandular and adenomatous polyps, are the most common in clinical practice, while non-mucosal polyps including gastric stromal tumors and inflammatory fibrous polyps are more common in clinical practice. Although the incidence of gastric polyps is far less than that of intestinal polyps, some pathological types, especially adenomatous polyps, have obvious malignant potential and are recognized as precancerous lesions .
Therefore, we retrospectively analyzed the records of patients with gastrointestinal polyps in our hospital in the past years, and provided epidemiological data to study the factors in polyps.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 43,104, patients (n=21939) with polyps and patients without polyps (n=21165) is included in this study.
Key inclusion criteria (1 listed)
- patients who underwent colonoscopies
Key exclusion criteria (1 listed)
- (1) Patients with Crohn's disease, inflammatory bowel disease, and colorectal cancer; (2) Patients with ulcerative bowel disease, and intestinal tuberculosis; (3) Patients with history of familial polyposis; (4) All patients without complete endoscopic reports and complete demographics records.
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
Influencing factors in patients with colorectal polyps: a retrospective study
Time frame: JUNE 30,2020
risk factors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Results publication: PubMed 32279448Han X, Qian W, Liu Y, Zheng T, Su XJ, Zhang PP, Chen Y, Hu LH, Li ZS. Effects of age, sex and pathological type on the risk of multiple polyps: A Chinese teaching hospital study. J Dig Dis. 2020 Sep;21(9):505-511. doi: 10.1111/1751-2980.12863.
- Results publication: PubMed 32192628Song M, Emilsson L, Bozorg SR, Nguyen LH, Joshi AD, Staller K, Nayor J, Chan AT, Ludvigsson JF. Risk of colorectal cancer incidence and mortality after polypectomy: a Swedish record-linkage study. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):537-547. doi: 10.1016/S2468-1253(20)30009-1. Epub 2020 Mar 17.
- Results publication: PubMed 21228314Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12.
- Results publication: PubMed 28842051Oines M, Helsingen LM, Bretthauer M, Emilsson L. Epidemiology and risk factors of colorectal polyps. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):419-424. doi: 10.1016/j.bpg.2017.06.004. Epub 2017 Jun 28.
- 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.
yue WANG, master principal investigator
the Human Ethics Committee of Jiangsu Provincial People's Hospital
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 Polyp, Colonic, run by The First Affiliated Hospital with Nanjing Medical University 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 1 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: finished, as of the sponsor's last update on 24 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Influencing factors in patients with colorectal polyps: a retrospective study (time frame: JUNE 30,2020). 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 NCT04444947, which also lists 4 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 24 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.