Gastro-esophageal Reflux DiseasePEPTESTCNNCT02456779
Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD
An observational study of Gastro-esophageal Reflux Disease, run by MAAB (Shanghai) Medical Device Limited at 9 sites in China.
Trial summary
The primary objective of this clinical study is to determine whether Peptest (Human Pepsin lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic methods commonly applied in clinical practice by testing a large number of clinical samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro-esophageal Reflux Disease
- What is being tested?
- in vitro diagnostic test (Peptest) and Questionnaire
- How many people
- 1,032 participants
- Where
- 9 sitesChina
- Study dates
- May 2015to Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: GERD patients Erosive Esophagitis (EE) Non-erosive reflux disease (NERD) Heathly controls with GERD symptoms
Who may be able to join
- Case group:
- 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:
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- 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.
Who cannot join
- Patients with functional heartburn.
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Jishuitan Hospital
Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
Huadong Hospital afflicted to Fudan University
Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai
Ruijin Hospital, School of Medicine, Shanghai Jiaotong University,
Shanghai
Shanghai East Hospital Affiliated to Tongji University
Shanghai
The Shanghai Tenth People's Hospital of Tongji University
Shanghai
Tongji Hospital, Tongji University School of Medicine
Shanghai
Zhongshan Hospital, Fudan University
Shanghai
About this study
Official title: Assessment of Equivalence of a Non-invasive In-vitro Diagnostic Test (Peptest) in Comparison to Other Routine Clinical Diagnostic Methods for GERD by Testing a Large Number of Clinical Samples
The primary objective of this clinical study is to determine whether Peptest (Human Pepsin lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic methods commonly applied in clinical practice by testing a large number of clinical samples.
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.
Read the detailed description
Gastroesophageal reflux disease (GERD) mainly manifests as three types, erosive esophagitis (EE), non-erosive reflux disease (NERD) and Barrett's esophagus. EE is characterized by damaged distal esophageal mucosa which is visible by endoscope, and also referred to as "endoscopically positive gastroesophageal reflux disease". NERD is defined as discomfort related to reflux without any obvious mucosal damage by endoscope, and is also known as "endoscopically negative gastroesophageal reflux disease".
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
- Gastro-esophageal Reflux Disease
- Being tested
- in vitro diagnostic test (Peptest), Questionnaire
- Keywords
- pepsin, peptest, GERD, NERD, diagnostic
- Medical subject headings
- Gastroesophageal Reflux, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro diagnostic test (Peptest)Other
Also called Peptest
saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest
QuestionnaireOther
Also called Reflux Disease Questionnaire (RDQ)
all recruited subjects to complete the RDQ as a determinant of inclusion criteria
QuestionnaireOther
Also called Reflux Symptom Index
control subjects to complete RSI as a determinant of inclusion criteria
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: in vitro diagnostic test (Peptest); Other: Questionnaire | |
| 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 Receives: Other: in vitro diagnostic test (Peptest); Other: Questionnaire | |
| 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 Receives: Other: in vitro diagnostic test (Peptest); Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peptest result (+ or -)
Proportion of GERD patients Peptest positive compared to controls that are Peptest postitive
Measured: baseline
Secondary outcomes (4)
Peptest result (+ or -)
Proportion of EE, NERD patients and control Peptest positive
Measured: baseline
Peptest result (+ or -)
Proportion of GERD patients Peptest positive within 15 minutes of symptoms
Measured: baseline
Peptest result (+ or -)
Proportion of Peptest positive in comparison to reference diagnostic test
Measured: baseline
Safety (adverse events)
adverse events reported
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal Reflux DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- MAAB (Shanghai) Medical Device Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RD Biomed Ltd
- Responsible party
- Sponsor
- Investigators
- Jing-Yuan Fang, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456779
- Sponsor's protocol ID
- PEPTESTCN
- Acronym
- PEPTESTCN
- Status last verified
- Dec 2017
- First submitted
- 21 May 2015
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Equivalence of a Non-invasive In-vitro Diagnostic Test (Peptest) in Comparison to Other Routine Clinical Diagnostic Methods for GERD by Testing a Large Number of Clinical Samples
- ClinicalTrials.gov ID
- NCT02456779
- Acronym / sponsor ID
- PEPTESTCN / PEPTESTCN
- Conditions
- Gastro-esophageal Reflux Disease
- Keywords
- pepsin, peptest, GERD, NERD, diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- MAAB (Shanghai) Medical Device LimitedIndustry (pharma, biotech, devices)
- Collaborators
- RD Biomed Ltd
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 29 May 2015 (estimated)
- 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.
The primary objective of this clinical study is to determine whether Peptest (Human Pepsin lateral flow in vitro diagnostic medical device) is equivalent to other GERD diagnostic methods commonly applied in clinical practice by testing a large number of clinical samples.
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
Gastroesophageal reflux disease (GERD) mainly manifests as three types, erosive esophagitis (EE), non-erosive reflux disease (NERD) and Barrett's esophagus. EE is characterized by damaged distal esophageal mucosa which is visible by endoscope, and also referred to as "endoscopically positive gastroesophageal reflux disease". NERD is defined as discomfort related to reflux without any obvious mucosal damage by endoscope, and is also known as "endoscopically negative gastroesophageal reflux disease".
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erosive Esophagitis | – | Other: in vitro diagnostic test (Peptest), Other: QuestionnairePatients 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 |
| non erosive reflux disease | – | Other: in vitro diagnostic test (Peptest), Other: QuestionnairePatients 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 |
| healthy controls | – | Other: in vitro diagnostic test (Peptest), Other: QuestionnaireNo GERD symptoms RDQ = 0 RSI = 0-9 Saliva samples to be obtained intervention: in vitro diagnostic test Peptest intervention: questionnaire intervention: questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- GERD patients Erosive Esophagitis (EE) Non-erosive reflux disease (NERD) Heathly controls with GERD symptoms
Key inclusion criteria (11 listed)
- 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 subjects without any symptoms of gastroesophageal reflux, extra-esophageal reflux and laryngopharyngeal reflux.
Key exclusion criteria (7 listed)
- Patients with functional heartburn.
- 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
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 |
|---|---|---|
| in vitro diagnostic test (Peptest)Also: Peptestsaliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest | Other | Erosive Esophagitis, healthy controls, non erosive reflux disease |
| QuestionnaireAlso: Reflux Disease Questionnaire (RDQ)all recruited subjects to complete the RDQ as a determinant of inclusion criteria | Other | Erosive Esophagitis, healthy controls, non erosive reflux disease |
| QuestionnaireAlso: Reflux Symptom Indexcontrol subjects to complete RSI as a determinant of inclusion criteria | Other | healthy controls |
Primary outcome
Peptest result (+ or -)
Time frame: baseline
Proportion of GERD patients Peptest positive compared to controls that are Peptest postitive
4 secondary outcomes
Peptest result (+ or -)
Time frame: baseline
Peptest result (+ or -)
Time frame: baseline
Peptest result (+ or -)
Time frame: baseline
Safety (adverse events)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
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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.
Jing-Yuan Fang principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-esophageal Reflux Disease, run by MAAB (Shanghai) Medical Device Limited at 9 sites 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peptest result (+ or -) (time frame: baseline). 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 8 Dec 2017.