Validation of a Non-invasive In-vitro Diagnostic Test (Peptest) Against Other Diagnostic Methods for GERD

NCT02456779 | Completed

• 1 other identifier: PEPTESTCN
• Study Type: observational
• Target: 1,032
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Gastro-esophageal Reflux Disease

Keywords

pepsin; peptest; GERD; NERD; diagnostic

Outcome Measures

Primary Outcomes (1)

• Peptest result (+ or -)

  Proportion of GERD patients Peptest positive compared to controls that are Peptest postitive

  baseline

Secondary Outcomes (4)

• Peptest result (+ or -)

  baseline

• Peptest result (+ or -)

  baseline

• Peptest result (+ or -)

  baseline

• Safety (adverse events)

  baseline

Study Arms (3)

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

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

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

Other: in vitro diagnostic test (Peptest); Other: Questionnaire

Interventions

in vitro diagnostic test (Peptest) OTHER

saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest

Also known as: Peptest

Erosive Esophagitis; healthy controls; non erosive reflux disease

Questionnaire OTHER

all recruited subjects to complete the RDQ as a determinant of inclusion criteria

Also known as: Reflux Disease Questionnaire (RDQ)

Erosive Esophagitis; healthy controls; non erosive reflux disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GERD patients Erosive Esophagitis (EE) Non-erosive reflux disease (NERD) Heathly controls with GERD symptoms

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MAAB (Shanghai) Medical Device Limited: lead
• RD Biomed Ltd: collaborator

Study Sites (9)

Beijing Jishuitan Hospital

Beijing, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Huadong Hospital afflicted to Fudan University

Shanghai, China

Location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

Location

Ruijin Hospital, School of Medicine, Shanghai Jiaotong University,

Shanghai, China

Location

Shanghai East Hospital Affiliated to Tongji University

Shanghai, China

Location

The Shanghai Tenth People's Hospital of Tongji University

Shanghai, China

Location

Tongji Hospital, Tongji University School of Medicine

Shanghai, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be obtained from each subject. Specimens will be disposed of after testing for presence of pepsin using Peptest.

MeSH Terms

Conditions

Gastroesophageal Reflux; Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jing-Yuan Fang

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 29, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

CN (9)