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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04444947
Other study ID # 2019-SR-340
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2019
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64889
Est. completion date June 1, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- patients who underwent colonoscopies

Exclusion Criteria:

- (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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Jiangsu Provincial People's Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Han X, Qian W, Liu Y, Zheng T, Su X, Zhang P, Chen Y, Hu L, Li Z. The Effect of Age, Sex and Pathologic Type on Risk of Multiple Polyps in a Chinese Teaching Hospital Based Study. J Dig Dis. 2020 Apr 12. doi: 10.1111/1751-2980.12863. [Epub ahead of print] — View Citation

Mariotto 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. Erratum in: J Natl Cancer Inst. 2011 Ap — View Citation

Øines 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. Review. — View Citation

Song 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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Influencing factors in patients with colorectal polyps: a retrospective study risk factors JUNE 30,2020
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