Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD
NCT ID: NCT02456779
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1032 participants
OBSERVATIONAL
2015-05-31
2017-11-30
Brief Summary
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This will be performed by evaluating Peptest results in GERD patients (Erosive esophagitis or NERD), defined using standard clinical procedures, and compared to healthy controls.
Detailed Description
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At present the diagnosis of GERD uses syndrome-based diagnosis, proton pump inhibitor (PPI) test, 24-hour esophageal pH monitoring, endoscopy, etc. However, some of the above methods lack specificity and some may bring great suffering to patients due to being invasive (e.g., 24-hour esophagus pH monitoring). The disadvantage of endoscopy lies in its low detection rate, only 2.95% to 4.1% as NERD is the most frequent diagnosis. Therefore, diagnosis based on GERD syndromes still remains one of the most common diagnostic methods. In recent years, questionnaire surveys about GERD have been carried out at abroad, aiming at finding a simple and feasible diagnostic method. As one of the worlds's most recognized and commonly used diagnostic scale for the diagnosis of GERD, reflux disease questionnaire (RDQ) is a survey of medical history mainly based on symptom score. Studies at both home and abroad have confirmed its validity and reliability in the diagnosis of GERD. The reflux symptom index (RSI) is a validated questionnaire used to confirm the presence (or absence) of extra-esophageal reflux that are atypical symptoms of reflux that control subjects may overlook.
Peptest (Human Pepsin lateral flow in vitro diagnostic medical device) can be used in clinic for fast and convenient pepsin detection in patients' saliva. Pepsin, detected from saliva samples, can be regarded as a marker of a reflux event for the diagnosis of gastroesophageal reflux disease.
The primary objective of this study is to determine whether Peptest (Human Pepsin lateral flow in vitro diagnostic medical device) produced by RD Biomed Limited is equivalent to other GERD diagnostic methods commonly applied in clinical practice by testing a large number of clinical samples.
GERD patients and controls will provide saliva samples and these will be tested for the presence of pepsin using Peptest. Peptest results (positive or negative) will be evaluated in GERD patients (Erosive esophagitis or NERD) defined using standard clinical diagnostic tools and compared to controls (confirmed to not have reflux using two validated questionnaires).
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Erosive Esophagitis
Patients diagnosed with GERD with erosive esophagitis present on routine endoscopy during the previous 6 months.
RDQ greater or equal to 12
Saliva samples to be obtained intervention: in vitro diagnostic test Peptest intervention: questionnaire
in vitro diagnostic test (Peptest)
saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest
Questionnaire
all recruited subjects to complete the RDQ as a determinant of inclusion criteria
non erosive reflux disease
Patients diagnosed with GERD with erosive esophagitis not present on routine endoscopy during the last 6 months.
RDQ greater or equal to 12
Saliva samples to be obtained intervention: in vitro diagnostic test Peptest intervention: questionnaire
in vitro diagnostic test (Peptest)
saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest
Questionnaire
all recruited subjects to complete the RDQ as a determinant of inclusion criteria
healthy controls
No GERD symptoms RDQ = 0 RSI = 0-9
Saliva samples to be obtained intervention: in vitro diagnostic test Peptest intervention: questionnaire intervention: questionnaire
in vitro diagnostic test (Peptest)
saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest
Questionnaire
all recruited subjects to complete the RDQ as a determinant of inclusion criteria
Questionnaire
control subjects to complete RSI as a determinant of inclusion criteria
Interventions
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in vitro diagnostic test (Peptest)
saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest
Questionnaire
all recruited subjects to complete the RDQ as a determinant of inclusion criteria
Questionnaire
control subjects to complete RSI as a determinant of inclusion criteria
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed as gastroesophageal reflux disease within 6 months had endoscopy within 6 months and presented with reflux symptoms in the past 4 weeks.
* Patients with RDQ questionnaire score of no less than 12 points.
* Patients who met the requirements and signed the informed consent.
* Collection and processing of samples should comply with the requirements of laboratory operation rules and product specifications.
Healthy group:
* Healthy subjects without any symptoms of gastroesophageal reflux, extra-esophageal reflux and laryngopharyngeal reflux.
* Healthy subjects with RDQ questionnaire score of 0.
* Healthy subjects with RSI questionnaire score of no more than 9 points and heartburn symptom score of 0.
* Healthy subjects who met the requirements and signed the informed consent.
* Collection and processing of samples should comply with the requirements of laboratory operation rules and product specifications.
Exclusion Criteria
* Patients who took gastric motor drugs within 7 days after entering the study.
* Patients with esophageal spasm and achalasia, eosinophilic esophagitis, dysphagia, esophageal or gastric cancer, and patients who received esophagus and stomach surgery
* Patients with serious hypohepatia or renal insufficiency
* Pregnant women
* Patients whose saliva samples were not appropriate for detection
* Samples not meeting the collection and processing requirements.
18 Years
ALL
Yes
Sponsors
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RD Biomed Ltd
UNKNOWN
MAAB (Shanghai) Medical Device Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jing-Yuan Fang
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Locations
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Beijing Jishuitan Hospital
Beijing, , China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Huadong Hospital afflicted to Fudan University
Shanghai, , China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, , China
Ruijin Hospital, School of Medicine, Shanghai Jiaotong University,
Shanghai, , China
Shanghai East Hospital Affiliated to Tongji University
Shanghai, , China
The Shanghai Tenth People's Hospital of Tongji University
Shanghai, , China
Tongji Hospital, Tongji University School of Medicine
Shanghai, , China
Zhongshan Hospital, Fudan University
Shanghai, , China
Countries
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Other Identifiers
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PEPTESTCN
Identifier Type: -
Identifier Source: org_study_id