Study of Faecal Bacteria Detection in Early Screening and Diagnosis of GC

November 19, 2020 updated by: Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine

Faecal Bacteria Detection in Early Screening and Diagnosis of Gastric Cancer: a Large-scale Multi-center Case-control Study

In this clinical trial, we aim to explore the synergistic alteration of specific bacteria both in gastric mucosas and feces of gastric cancer patients for the method of non-invasive and cost-effective faecal marker detection. We aim to select and validate specific microbes as noninvasive, accurate, simple, sensitive and highly-accepted biomarkers that might assist to screen and diagnose gastric cancer, especially early gastric cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We conducted a large-scale multi-centre retrospective case-control study. Approximately a total of 1080 volunteers aging 40-75 in three independent cohorts, discovery cohort, validation cohort 1, validation cohort 2, will be recruited from 10 hospitals throughout China. Among them, 530 subjects in both discovery cohort and validation cohort 1 were from Shanghai Jiao Tong University School of Medicine Renji Hospital from August to December in 2018. Around 550 participants will be enrolled in validation cohort 2 from nine hospitals in China.Each cohort recruits both patients diagnosed with GC (GC group) and gender, age and body mass index (BMI)-matched healthy-control (HC) individuals diagnosed with chronic gastritis by histopathology). Individuals enrolled were either asymptomatic undergoing upper GI endoscopy screening or went to GI clinic with digestive symptoms. Subjects in HC group are conducted colonoscopy within 0.5 year before or after upper endoscopy. We collect gastric tissue biopsies and stool samples from gastric cancer patients and healthy-controls. First in the discovery cohort, which will recruit 20 subjects, 13 pairs of both cancerous & noncancerous gastric tissues and pre-operation feces in GC group will be collected. 7 subjects provide their paired mucosal biopsies and stools in HC group before examination. 16S ribosomal RNA gene sequencing will be used to select the synergistically differential bacteria species as well as find out microbial compositional distinction and diversity from both tissue and stool samples between GC and HC group. Second, the validation cohort 1 recruiting a total of 510 subjects (294 GC patients and 216 HC individuals), 217 pre-operation faecal specimens and 141 fresh tissues (cancerous & noncancerous tissues) from GC group, and 127 faecal samples and 124 gastric biopsies will be collected. Quantitative PCR (qPCR) will be used to validate the high-throughput sequencing results in discovery cohort in a single center. Among them, 35 objects in HC group and 64 patients in GC group will provide their paired tissues and feces. Third, in validation cohort 2, we are going to enroll volunteers from multiple geographic locations to confirm our results. 550 stool samples will be collected to further validate the accuracy, sensitivity and specificity of the cut-off value analyzed from validation cohort 1. All results of laboratory tests including tumor markers CEA, CA199,CA724 were obtained from the electronic query system. The GC stages will be assessed by the TNM system according to AJCC Version 4.2017 based on surgical records, histopathology and radiographic images (eg. PET-CT, abdominal enhanced CT). All subjects will sign up informed consent form before sample collection. The protocol of present study was approved by Ethics Review Committee of all participating hospitals.

Study Type

Observational

Enrollment (Anticipated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Ninth People's Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Jing'an District Central Hospital of Shanghai
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
        • Contact:
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • Department of Gastroenterology, Zhongshan Hospital, Xiamen University
        • Contact:
    • Guangzhou
      • Guangdong, Guangzhou, China
        • Recruiting
        • Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Completed
        • Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants are required to complete a structured questionnaire for assessment of inclusion requirement.

Description

Inclusion Criteria:

  • 1）Age between 40 and 75;
  • 2）Subjects in GC group are pathologically diagnosed as gastric cancer prior to any treatment such as surgery, endoscopic resection, chemotherapy, radiotherapy, immunotherapy, traditional Chinese medicine therapy, etc. The results of their preoperative abdominal enhanced CT or PET-CT indicated no obvious bowel abnormalities (inflammation, polyps, ulcers, tumors, erosions, melanosis, etc.);
  • 3) Subjects in HC group are diagnosed with chronic gastritis by endoscopy and pathology. without ulcers, polyps, tumors, severe erosions or bile reflux, and no obvious abnormal findings (inflammation, polyps, ulcers, tumors, erosions, melanosis, etc.) by colonoscopy within half a year;
  • 4) Subjects are willing to cooperate with this research and provide stool/mucosa samples as required.

Exclusion Criteria:

  • 1) with severe systemic infection, nasopharyngeal/oral cavity inflammation (periodontitis, gingivitis, tonsillitis, etc.), respiratory tract infection, soft tissue or skin infection, abscess or endocarditis within 3 months prior to recruitment;
  • 2）prior medication history of the following medicine within 3 months: nonsteroidal anti-inflammatory drugs (NSAIDs), immunosuppressor, antibiotics, probiotics, hormones or immune-suppressants at least 1 week;
  • 3）prior medication history of proton-pump inhibitors or H2 receptor inhibitors for over 2 months within 1 year;
  • 4) with a history of H.pylori eradication therapy within 1 year;
  • 5) with severe constipation, diarrhea or defecation habits changes within 3 months;
  • 6) personal history of cancer, organ transplantation, parasites infection or other severe digestive system diseases (inflammatory bowel disease, liver cirrhosis, etc.);
  • 7) with uncontrolled digestive bleeding, obstruction, perforation and any trauma or surgery within 3 months;
  • 8) with uncontrolled chronic metabolic or endocrine disorders, e.g. hypertension, diabetes, hyperlipidemia, hyperuricemia, etc.
  • 9) on a vegetarian diet or with great changes of eating habits within 3 months;
  • 10) refusal of participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GC
patients diagnosed with GC
Other: collect gastric tissue and stool samples
collect gastric tissue and stool samples
HC
patients diagnosed with chronic gastritis by histopathology
Other: collect gastric tissue and stool samples
collect gastric tissue and stool samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences in abundance of gut microbiota
Time Frame: 1 year
differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evidence of gastric carcinoma
Time Frame: 1 year
Different outcomes for gastric carcinoma confirmed by endoscopy and pathology
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic information of patients with different clinical outcomes
Time Frame: 1 year
Basic information of patients with different clinical outcomes by a questionnaire
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Zhongshan Hospital Xiamen University
Nanfang Hospital of Southern Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Ruijin Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Tianjin Medical University General Hospital
Shanghai Changzheng Hospital
Jing'an District Central Hospital of Shanghai
Seventh Medical Center of PLA Army General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY[2019]130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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