Colorectal NeoplasmsNCT05832372
Esophagogastric Histopathology Potentially Guided Patients Younger Than 50 Years Old to Undergo Colonoscopy Earlier
An observational study of Colorectal Neoplasms, run by Shandong University.
Trial summary
Colorectal cancer (CRC) is the third most diagnosed cancer worldwide and second leading cause of cancer death. Most CRCs arise from a polyp, developing through two major precursor lesion pathways: the traditional adenoma-carcinoma pathway, and the serrated neoplasia pathway. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 27 May 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: This retrospective observational study analyzed records between November 7, 2020, and November 14, 2022 which were extracted from Qilu Hospital of Shandong University. Patients younger than 50 years old who underwent gastroscopy and colonoscopy simultaneously, were selected and enrolled.
Who may be able to join
- Patients younger than 50 years old who underwent gastroscopy and colonoscopy simultaneously.
Who cannot join
- Patients without a good bowel preparation (Boston Bowel Preparation Scale [BBPS] score ≥ 6);
- Incomplete gastroscopy or colonoscopy examinations;
- Partial or total gastrointestinal resection;
- Patients who have been diagnosed with gastrointestinal cancer before endoscopy;
- Hereditary polyposis, including Peutz-Jeghers syndrome, and familial adenomatous polyposis;
- A history of inflammatory bowel diseases.
About this study
Official title: Esophagogastric Histopathology Potentially Guided Patients Younger Than 50 Years Old to Undergo Colonoscopy Earlier: A Retrospective Cross-sectional Study
Colorectal cancer (CRC) is the third most diagnosed cancer worldwide and second leading cause of cancer death. Most CRCs arise from a polyp, developing through two major precursor lesion pathways: the traditional adenoma-carcinoma pathway, and the serrated neoplasia pathway. This provides opportunities to prevent cancer by removing its precursor lesions. CRC screening efforts are directed toward removal of precancerous polyps with colonoscopy and detection of early-stage CRC, which has been demonstrated to reduce CRC incidence and mortality effectively, making CRC one of the most preventable and treatable forms of cancer.
Current guidelines in China recommend starting CRC screening uniformly at age 50 in average-risk individuals. However, a one-fits-all approach to determining CRC screening starting age may be not conducive to personalized screening, especially in the developing countries with scarce health resources. The incidence of early-onset CRC (CRC diagnosed before the age of 50) has shown a continuous increasing trend worldwide, spurring the US Preventive Services Task Force to recommend initiating average-risk CRC screening at age 45 instead of 50. Furthermore, different populations may benefit from even earlier screening, and CRC incidence may differ on the basis of population characteristics and CRC risk factors. For individuals younger than 50 years old, earlier screening based on risk factors may address this concern.
Previous studies have recommended earlier starting age of CRC screening combined with risk factors such as but not limited to sex, age, family history, lifestyle and comorbidity. Some upper gastrointestinal diseases have also been reported to be associated with an increased risk of colorectal neoplasms, which may be related to the destruction of gastric acid barrier function and long-term use of pump proton inhibitors. Compared with colonoscopy examination, individuals were more willing to undergo esophagogastroduodenoscopy (EGD) examination for gastric cancer screening, especially among the younger, potentially utilizing the EGD to guide earlier colonoscopies for patients at increased risk. Therefore, this study was aimed to investigate the association between esophagogastric histopathology and colorectal neoplasms in patients under the age of 50 and whether these risks factor could be combined with to guide earlier CRC screening.
- Conditions
- Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal colonoscopy group | Individuals with normal colonoscopy examination | |
| Colorectal polyps group | Individuals with colorectal polyps diagnosed by colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence or occurrence of upper gastrointestinal diseases
Including Helicobacter pylori, atrophic gastritis/intestinal metaplasia, reflux esophagitis, Barrett's esophagus, peptic ulcer, gastric polyps, low-grade intraepithelial neoplasia (LGIN), and high-grade intraepithelial neoplasia (HGIN).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion27 May 2023 (estimated)
- Study completion27 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832372
- Sponsor's protocol ID
- 2023033
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 27 Apr 2023
- 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophagogastric Histopathology Potentially Guided Patients Younger Than 50 Years Old to Undergo Colonoscopy Earlier: A Retrospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05832372
- Acronym / sponsor ID
- 2023033
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 27 May 2023 (estimated)
- Study completion
- 27 May 2023 (estimated)
- First posted
- 27 Apr 2023 (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.
Colorectal cancer (CRC) is the third most diagnosed cancer worldwide and second leading cause of cancer death. Most CRCs arise from a polyp, developing through two major precursor lesion pathways: the traditional adenoma-carcinoma pathway, and the serrated neoplasia pathway. This provides opportunities to prevent cancer by removing its precursor lesions. CRC screening efforts are directed toward removal of precancerous polyps with colonoscopy and detection of early-stage CRC, which has been demonstrated to reduce CRC incidence and mortality effectively, making CRC one of the most preventable and treatable forms of cancer.
Current guidelines in China recommend starting CRC screening uniformly at age 50 in average-risk individuals. However, a one-fits-all approach to determining CRC screening starting age may be not conducive to personalized screening, especially in the developing countries with scarce health resources. The incidence of early-onset CRC (CRC diagnosed before the age of 50) has shown a continuous increasing trend worldwide, spurring the US Preventive Services Task Force to recommend initiating average-risk CRC screening at age 45 instead of 50. Furthermore, different populations may benefit from even earlier screening, and CRC incidence may differ on the basis of population characteristics and CRC risk factors. For individuals younger than 50 years old, earlier screening based on risk factors may address this concern.
Previous studies have recommended earlier starting age of CRC screening combined with risk factors such as but not limited to sex, age, family history, lifestyle and comorbidity. Some upper gastrointestinal diseases have also been reported to be associated with an increased risk of colorectal neoplasms, which may be related to the destruction of gastric acid barrier function and long-term use of pump proton inhibitors. Compared with colonoscopy examination, individuals were more willing to undergo esophagogastroduodenoscopy (EGD) examination for gastric cancer screening, especially among the younger, potentially utilizing the EGD to guide earlier colonoscopies for patients at increased risk. Therefore, this study was aimed to investigate the association between esophagogastric histopathology and colorectal neoplasms in patients under the age of 50 and whether these risks factor could be combined with to guide earlier CRC screening.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal colonoscopy group | – | –Individuals with normal colonoscopy examination |
| Colorectal polyps group | – | –Individuals with colorectal polyps diagnosed by colonoscopy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This retrospective observational study analyzed records between November 7, 2020, and November 14, 2022 which were extracted from Qilu Hospital of Shandong University. Patients younger than 50 years old who underwent gastroscopy and colonoscopy simultaneously, were selected and enrolled.
Key inclusion criteria (1 listed)
- Patients younger than 50 years old who underwent gastroscopy and colonoscopy simultaneously.
Key exclusion criteria (6 listed)
- Patients without a good bowel preparation (Boston Bowel Preparation Scale [BBPS] score ≥ 6);
- Incomplete gastroscopy or colonoscopy examinations;
- Partial or total gastrointestinal resection;
- Patients who have been diagnosed with gastrointestinal cancer before endoscopy;
- Hereditary polyposis, including Peutz-Jeghers syndrome, and familial adenomatous polyposis;
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
Prevalence or occurrence of upper gastrointestinal diseases
Time frame: 1 year
Including Helicobacter pylori, atrophic gastritis/intestinal metaplasia, reflux esophagitis, Barrett's esophagus, peptic ulcer, gastric polyps, low-grade intraepithelial neoplasia (LGIN), and high-grade intraepithelial neoplasia (HGIN).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Shandong University.
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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevalence or occurrence of upper gastrointestinal diseases (time frame: 1 year). 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 27 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.