NCT05196243

Brief Summary

Mitochondrial DNA mutations in normal gastric tissue, early gastric cancer and advanced gastric cancer were identified by single cell sequencing, and the origin of gastric stem cells was traced and new molecular markers were found. At the same time, organize industry-university-research-medical inspection joint research, aiming at the advanced layout of new structural and functional imaging technologies, combined with some new imaging technologies, such as holography, fluorescence, etc., to explore and develop a new composite endoscopic imaging technology that is advanced, original and suitable for China's national conditions, in order to develop a prototype of multimodal structural and functional imaging digestive endoscope without contrast agent.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

January 5, 2022

Last Update Submit

March 20, 2022

Conditions

Keywords

Mitochondrial DNA MutationSingle cell sequencingMolecular pathologymultimodal imagingholography

Outcome Measures

Primary Outcomes (2)

  • Single cell sequencing and identification of mitochondrial DNA variation in gastrointestinal lesions

    Single cell sequencing and identification of mitochondrial DNA mutations in gastrointestinal lesions were carried out to trace the clonal origin of cells and look for molecular markers

    1 month

  • To explore the multimodal imaging technique for the diagnosis of gastrointestinal mucosal lesions

    The tissue characteristics are analyzed by the full spectrum imaging device, the location, distribution and aggregation of key molecules on the cell membrane are observed by the high resolution imaging device, the imaging probe with high labeling efficiency and biosafety is developed, and the clinical application is discussed. in order to realize the information fusion of structural and functional imaging in the process of gastrointestinal tumor evolution and diagnosis and treatment.

    1 month

Study Arms (2)

Study Group

Study on the genomic and molecular pathological characteristics of gastrointestinal mucosal lesions

Other: Patients diagnosed as gastrointestinal mucosal lesions

Control Group

Study on the genomic and molecular pathological characteristics of normal gastrointestinal mucosa

Interventions

Patients diagnosed as gastritis, gastric cancer, intestinal polyps and colorectal cancer

Study Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People diagnosed or suspected of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, colorectal cancer

You may qualify if:

  • Diagnosis or suspected diagnosis of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, bowel cancer
  • Written informed consent

You may not qualify if:

  • Patients with cardiovascular and cerebrovascular diseases, or patients with severe impairment of liver, kidney and hematopoietic system
  • Mental patients
  • Hemorrhagic diseases
  • Platelet count \< 50 × 10 \^ 9 / L
  • Allergic constitution
  • unable to tolerate or cooperate with endoscopy
  • Patients with serious complications, such as intestinal obstruction, intestinal perforation, toxic colonic dilatation, colorectal cancer, etc.
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Mucosal tissues or cells of gastritis, gastric cancer, intestinal polyps and colorectal cancer obtained by endoscopic biopsy or resection

Study Officials

  • Yan Liu, MD

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 19, 2022

Study Start

March 21, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2024

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations