Non-invasive and Sensitive Faecal Bacterial Markers for Early Screening and Diagnosis of Gastric CancerNCT04638959
Study of Faecal Bacteria Detection in Early Screening and Diagnosis of GC
An observational study of Non-invasive and Sensitive Faecal Bacterial Markers for Early Screening and Diagnosis of Gastric Cancer, run by Shanghai Jiao Tong University School of Medicine at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-invasive and Sensitive Faecal Bacterial Markers for Early Screening and Diagnosis of Gastric Cancer
- What is being tested?
- collect gastric tissue and stool samples
- How many people
- 1,100 participants
- Where
- 10 sitesChina
- Study dates
- 30 Sep 2019to 30 Sep 2021
- How long will I take part?
- 2 Years
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are required to complete a structured questionnaire for assessment of inclusion requirement.
Who may be able to join
- 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.
Who cannot join
- 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.);
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 9 recruiting
- Recruiting
Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
Beijing, Beijing Municipality
Jian-Qiu Sheng, 13601187561, jianqiu@263.net
- Recruiting
Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
Guangdong, Guangzhou
Si-De Liu, 139022122459, liuside@163.com
- Recruiting
Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School
Nanjing, Jiangsu
Xiao-Ping Zou, 13770771661, zouxiaoping795@hoymail.com
- 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
Shanghai, Shanghai Municipality, 200001
- Recruiting
Jing'an District Central Hospital of Shanghai
Shanghai
Hong Wang, 13816537860, wanghongjzx@aliyun.com
- Recruiting
Shanghai Changzheng Hospital
Shanghai
Wei-Fen Xie, 13701682806, weifenxie@medmail.com.cn
- Recruiting
Shanghai Ninth People's Hospital
Shanghai
Xiang-Jun Meng, 13816170604, xiangjunmeng@aliyun.com
- Recruiting
Shanghai Ruijin Hospital
Shanghai
Yun-Wei Sun, 13917759901, sun_yunwei@qq.com
- Recruiting
Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality
Bang-Mao Wang, 13602007150, gi.tmuh@sohu.com
- Recruiting
Department of Gastroenterology, Zhongshan Hospital, Xiamen University
Xiamen, Fujian
Jian-Lin Ren, 13606910859, jianlin.ren@126.com
About this study
Official title: 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.
Read the 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.
- Being tested
- collect gastric tissue and stool samples
- Keywords
- faecal bacterial marker, early screening and diagnosis, gastric cancer
- Medical subject headings
- Disease, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect gastric tissue and stool samplesOther
collect gastric tissue and stool samples
| Study group | Role | What they receive |
|---|---|---|
| GC | patients diagnosed with GC Receives: Other: collect gastric tissue and stool samples | |
| HC | patients diagnosed with chronic gastritis by histopathology Receives: Other: collect gastric tissue and stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (1)
evidence of gastric carcinoma
Different outcomes for gastric carcinoma confirmed by endoscopy and pathology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start30 Sep 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-invasive and Sensitive Faecal Bacterial Markers for Early Screening and Diagnosis of Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, Ruijin Hospital, Jing'an District Central Hospital of Shanghai, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Nanfang Hospital, Southern Medical University, Seventh Medical Center of PLA Army General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Zhongshan Hospital Xiamen University, Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638959
- Sponsor's protocol ID
- KY[2019]130
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35167866
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Bacteria Detection in Early Screening and Diagnosis of Gastric Cancer: a Large-scale Multi-center Case-control Study
- ClinicalTrials.gov ID
- NCT04638959
- Acronym / sponsor ID
- KY[2019]130
- Keywords
- faecal bacterial marker, early screening and diagnosis, gastric cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, Ruijin Hospital, Jing'an District Central Hospital of Shanghai, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Nanfang Hospital, Southern Medical University, Seventh Medical Center of PLA Army General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Zhongshan Hospital Xiamen University, Tianjin Medical University General Hospital
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 20 Nov 2020 (actual)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC | – | Other: collect gastric tissue and stool samplespatients diagnosed with GC |
| HC | – | Other: collect gastric tissue and stool samplespatients diagnosed with chronic gastritis by histopathology |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are required to complete a structured questionnaire for assessment of inclusion requirement.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| collect gastric tissue and stool samplescollect gastric tissue and stool samples | Other | GC, HC |
Primary outcome
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 secondary outcome
evidence of gastric carcinoma
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 35167866Zhou 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.
- Individual participant dataSharing planned: No
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.
Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital
Beijing, China
Department of Gastroenterology, Zhongshan Hospital, Xiamen University
Xiamen, China
Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity
Guangdong, China
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive and Sensitive Faecal Bacterial Markers for Early Screening and Diagnosis of Gastric Cancer, run by Shanghai Jiao Tong University School of Medicine at 10 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in abundance of gut microbiota (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638959, which also lists 1 linked publication.
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 20 Nov 2020.