Status Approved
First Submitted Date
2019/09/06
Registered Date
2019/09/16
Last Updated Date
2019/09/10
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0004295 |
|---|---|
| Unique Protocol ID | 2019-04-134-001 |
| Public/Brief Title | Evaluation of diagnostic accuracy of PEPTEST, a non-invasive test for the diagnosis of gastroesophageal reflux disease |
| Scientific Title | Evaluation of diagnostic accuracy of PEPTEST, a non-invasive test for the diagnosis of gastroesophageal reflux disease |
| Acronym | |
| MFDS Regulated Study | Yes |
| IND/IDE Protocol | |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | SMC 2019-04-134-001 |
| Approval Date | 2019-08-07 |
| Institutional Review Board Name | Samsung Medical Center Institutional Review Board |
| Institutional Review Board Address | 81, Irwon-ro, Gangnam-gu, Seoul |
| Institutional Review Board Telephone | 02-3410-2973 |
| Data Monitoring Committee |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | yangwon Min |
| Title | professor |
| Telephone | +82-2-3410-3000 |
| Affiliation | Samsung Medical Center |
| Address | 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea |
| Contact Person for Public Queries | |
| Name | yangwon Min |
| Title | professor |
| Telephone | +82-2-3410-3000 |
| Affiliation | Samsung Medical Center |
| Address | 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea |
| Contact Person for Updating Information | |
| Name | yangwon Min |
| Title | professor |
| Telephone | +82-2-3410-3000 |
| Affiliation | Samsung Medical Center |
| Address | 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Not yet recruiting | |
| Date of First Enrollment | 2019-09-23 Anticipated | |
| Target Number of Participant | 100 | |
| Primary Completion Date | ||
| Study Completion Date | ||
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Samsung Medical Center | |
| Recruitment Status | Not yet recruiting | |
| Date of First Enrollment | 2019-09-23 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Samsung Medical Center |
| Organization Type | Medical Institute |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Samsung Medical Center |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Gastroesophageal reflux disease (GERD) can be diagnosed for typical symptoms such as heartburn and reflux. However, if the patient complains of atypical symptoms or does not respond well to PPI treatment, the diagnosis needs to be clarified. For accurate diagnosis, 24-hour impedance/pH testing is usually performed, but it is invasive and expensive, uncomfortable for patients. Peptest is a test that can quantitatively measure the concentration of pepsin in saliva and indirectly demonstrate gastroesophageal reflux. Peptest is being researched in many countries, but reports mismatched results. The purpose of this study is to evaluate the accuracy of diagnosis and to establish the optimal implementation method. |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Case-only |
| Time Perspective | Prospective |
| Target Number of Participant | 100 |
| Cohort/Group Number | 1 |
|
Cohort/ Group 1 |
Cohort/Group Label Suspicious of GERD patients |
|
Cohort/Group Description Comparison of Peptest concordance with 24-hour impedance/pH testing |
|
| Biospecimen Collection & Archiving |
: DNA Collect & Archive: Sample without DNA |
| Biospecimen Description | saliva |
9. Subject Eligibility
| Study Population Description | Adults over 18 years old who visited Samsung Medical Center with symptoms of GERD |
|---|---|
| Sampling Method | 1. Patients with typical GERD symptoms (heartburn, regurgitation) do not respond PPI treatment. 2. Patients with atypical symptoms (chest pain, foreign body, cough) of GERD. Non-probability sampling method to perform 24-hour impedance/pH testing in the patient |
| Condition(s)/Problem(s) |
* (K00-K93)Diseases of the digestive system (K21.9)Gastro-oesophageal reflux disease without oesophagitis Gastroesophageal Reflux |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 18Year~No Limit |
|
|
Description Patient who have gastroesophageal reflux symptoms |
|
| Exclusion Criteria |
1. Patients under 18 years old 2. Patients who have had past gastric or esophageal surgery 3. Patients taking proton pump inhibitors and histamine receptor blockers 4. Esophageal disorders such as achalasia and diffuse esophageal spasms 5. Patients with difficulty collecting saliva |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | Not applicable | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | sensitivity and specificity |
|
| Timepoint | At the end of the study |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Positive predictive value and negative predictive value |
|
| Timepoint | At the end of the study |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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