Symptoms and SignsNCT03736824
Correlation of Endoscopic Findings and Symptoms in Patients Undergoing the First Upper Gastrointestinal Endoscopy
An observational study of Symptoms and Signs and Malignancy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Endoscopy is the best means of finding early stage of upper gastrointestinal diseases, especially early cancer and benign ulcers. Currently, most people still undergo upper gastrointestinal endoscopy due to discomfort, rather than a regular physical examination at a certain age. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Symptoms and Signs, Malignancy, Ulcer Peptic
- What is being tested?
- endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing the first upper gastrointestinal endoscopy were collected from January 2018 to December 2018 in Renji Hospital, Shanghai Jiaotong University School of Medicine.
Who may be able to join
- Patients undergoing the first upper gastrointestinal endoscopy.
Who cannot join
- The patients had previously performed endoscopy and any esophageal, gastric or duodenal surgery.
- The patients couldn't complete the questionnaire survey under the guidance of physicians at the appointment of the upper gastrointestinal endoscopy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Huiyi Li, MD, +8613761902402, lhy177279@163.com
About this study
Endoscopy is the best means of finding early stage of upper gastrointestinal diseases, especially early cancer and benign ulcers. Currently, most people still undergo upper gastrointestinal endoscopy due to discomfort, rather than a regular physical examination at a certain age. This study prospectively investigated the reason for undergoing the first upper gastrointestinal endoscopy in patients and found the correlation of endoscopic findings and symptoms.
- Conditions
- Symptoms and Signs, Malignancy, Ulcer Peptic
- Being tested
- endoscopy
- Medical subject headings
- Signs and Symptoms, Neoplasms, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyProcedure or surgery
All endoscopy was performed by qualified gastroenterologists or endoscopic physicians in Renji hospital,Shanghai Jiaotong University School of Medicine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of endoscopic findings and symptoms
survey
Measured: Within two weeks after receiving the survey
Secondary outcomes (3)
The proportion of various symptoms in patients undergoing the first upper gastrointestinal endoscopy
Measured: Within two weeks after receiving the survey
The proportion of different upper gastrointestinal diseases
Diagnosis of upper gastrointestinal disease combined with endoscopic findings and pathological diagnosis.
Measured: Within two weeks after receiving the survey
The infection rate of Helicobacter Pylori
- pylori infection was determined by any two of positive outcome of the breath test, rapid urease test and histology.
Measured: Within two weeks after receiving the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Jan 2018
- Primary completion30 Nov 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms and SignsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong 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
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hong Lu, Study director, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736824
- Sponsor's protocol ID
- rjyy20181021
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Endoscopic Findings and Symptoms in Patients Undergoing the First Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT03736824
- Acronym / sponsor ID
- rjyy20181021
- Conditions
- Symptoms and Signs, Malignancy, Ulcer Peptic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Nov 2018 (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.
Endoscopy is the best means of finding early stage of upper gastrointestinal diseases, especially early cancer and benign ulcers. Currently, most people still undergo upper gastrointestinal endoscopy due to discomfort, rather than a regular physical examination at a certain age. This study prospectively investigated the reason for undergoing the first upper gastrointestinal endoscopy in patients and found the correlation of endoscopic findings and symptoms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing the first upper gastrointestinal endoscopy were collected from January 2018 to December 2018 in Renji Hospital, Shanghai Jiaotong University School of Medicine.
Key inclusion criteria (1 listed)
- Patients undergoing the first upper gastrointestinal endoscopy.
Key exclusion criteria (2 listed)
- The patients had previously performed endoscopy and any esophageal, gastric or duodenal surgery.
- The patients couldn't complete the questionnaire survey under the guidance of physicians at the appointment of the upper gastrointestinal endoscopy.
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 |
|---|---|---|
| endoscopyAll endoscopy was performed by qualified gastroenterologists or endoscopic physicians in Renji hospital,Shanghai Jiaotong University School of Medicine. | Procedure or surgery | – |
Primary outcome
Correlation of endoscopic findings and symptoms
Time frame: Within two weeks after receiving the survey
survey
3 secondary outcomes
The proportion of various symptoms in patients undergoing the first upper gastrointestinal endoscopy
Time frame: Within two weeks after receiving the survey
The proportion of different upper gastrointestinal diseases
Time frame: Within two weeks after receiving the survey
The infection rate of Helicobacter Pylori
Time frame: Within two weeks after receiving the survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- 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.
Hong Lu study director
School of Medicine, Shanghai Jiao Tong University
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 Symptoms and Signs and Malignancy, run by Shanghai Jiao Tong 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 1 inclusion and 2 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 2018. 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?
Contact Huiyi Li (+8613761902402, lhy177279@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of endoscopic findings and symptoms (time frame: Within two weeks after receiving the survey). 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 2018.