NCT04638959

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

November 18, 2020

Last Update Submit

November 19, 2020

Conditions

Non-invasive and Sensitive Faecal Bacterial Markers for Early Screening and Diagnosis of Gastric Cancer

Keywords

faecal bacterial markerearly screening and diagnosisgastric cancer

Outcome Measures

Primary Outcomes (1)

  • differences in abundance of gut microbiota

    differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)

    1 year

Secondary Outcomes (1)

  • evidence of gastric carcinoma

    1 year

Other Outcomes (1)

  • Basic information of patients with different clinical outcomes

    1 year

Study Arms (2)

GC

patients diagnosed with GC

Other: collect gastric tissue and stool samples

HC

patients diagnosed with chronic gastritis by histopathology

Other: collect gastric tissue and stool samples

Interventions

collect gastric tissue and stool samplesOTHER

collect gastric tissue and stool samples

GCHC

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ）Age between 40 and 75;
  • ）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.);
  • \) 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;
  • \) Subjects are willing to cooperate with this research and provide stool/mucosa samples as required.

You may not qualify if:

  • \) 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;
  • ）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;
  • ）prior medication history of proton-pump inhibitors or H2 receptor inhibitors for over 2 months within 1 year;
  • \) with a history of H.pylori eradication therapy within 1 year;
  • \) with severe constipation, diarrhea or defecation habits changes within 3 months;
  • \) personal history of cancer, organ transplantation, parasites infection or other severe digestive system diseases (inflammatory bowel disease, liver cirrhosis, etc.);
  • \) with uncontrolled digestive bleeding, obstruction, perforation and any trauma or surgery within 3 months;
  • \) with uncontrolled chronic metabolic or endocrine disorders, e.g. hypertension, diabetes, hyperlipidemia, hyperuricemia, etc.
  • \) on a vegetarian diet or with great changes of eating habits within 3 months;
  • \) refusal of participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Department of Gastroenterology, Zhongshan Hospital, Xiamen University

Xiamen, Fujian, China

RECRUITING

Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity

Guangdong, Guangzhou, China

RECRUITING

Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

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

Shanghai, Shanghai Municipality, 200001, China

COMPLETED

Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

RECRUITING

Jing'an District Central Hospital of Shanghai

Shanghai, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

Shanghai Ninth People's Hospital

Shanghai, China

RECRUITING

Shanghai Ruijin Hospital

Shanghai, China

RECRUITING

Related Publications (1)

  • Zhou CB, Pan SY, Jin P, Deng JW, Xue JH, Ma XY, Xie YH, Cao H, Liu Q, Xie WF, Zou XP, Sheng JQ, Wang BM, Wang H, Ren JL, Liu SD, Sun YW, Meng XJ, Zhao G, Chen JX, Cui Y, Wang PQ, Guo HM, Yang L, Chen X, Ding J, Yang XN, Wang XK, Qian AH, Hou LD, Wang Z, Chen YX, Fang JY. Fecal Signatures of Streptococcus anginosus and Streptococcus constellatus for Noninvasive Screening and Early Warning of Gastric Cancer. Gastroenterology. 2022 Jun;162(7):1933-1947.e18. doi: 10.1053/j.gastro.2022.02.015. Epub 2022 Feb 12.

    PMID: 35167866DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

gastric cancer tissues gastric mucosa stools

MeSH Terms

Conditions

DiseaseStomach Neoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 20, 2020

Study Start

September 30, 2019

Primary Completion

March 31, 2021

Study Completion

September 30, 2021

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)