Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04638959
Status:
UNKNOWN
Last Update Posted:
2020-11-20
First Post:
2020-11-18
Brief Title:
Study of Faecal Bacteria Detection in Early Screening and Diagnosis of GC
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Faecal Bacteria Detection in Early Screening and Diagnosis of Gastric Cancer a Large-scale Multi-center Case-control Study
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ChinaEach 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 05 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 CA199CA724 were obtained from the electronic query system The GC stages will be assessed by the TNM system according to AJCC Version 42017 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None