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Multimodal Imaging Based on Pathological and Genomic Characteristics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05196243
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment
Mitochondrial DNA Mutation Endoscopy Other: Patients diagnosed as gastrointestinal mucosal lesions

Detailed Description:
In this study, on the basis of previous work, aiming at the visualization of key molecular functions of gastric cancer, a full-chain digestive endoscopic diagnosis system was constructed by using cross-scale medical imaging technology. 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. The tissue characteristics are analyzed by the full spectrum imaging device, and the location, distribution and aggregation of key molecules on the cell membrane are observed by the high resolution imaging device, so as to develop an imaging probe with high labeling efficiency and biosafety, and to explore its clinical application to realize the information fusion of structural and functional imaging in the evolution and diagnosis and treatment of gastrointestinal tumors. The structural heterogeneity and molecular heterogeneity of gastrointestinal tumors are clarified from the macro-micro levels, and the full-scale imaging system with the most comprehensive visualization and resolution ability is established from multi-information dimensions and multi-imaging scales.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A New Multimodal Imaging Technique Based on Pathological and Genomic Characteristics of Gastrointestinal Mucosa
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Study Group
Study on the genomic and molecular pathological characteristics of gastrointestinal mucosal lesions
 Other: Patients diagnosed as gastrointestinal mucosal lesions
Patients diagnosed as gastritis, gastric cancer, intestinal polyps and colorectal cancer
Control Group
Study on the genomic and molecular pathological characteristics of normal gastrointestinal mucosa


Outcome Measures
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Primary Outcome Measures :
  1. Single cell sequencing and identification of mitochondrial DNA variation in gastrointestinal lesions [ Time Frame: 1 month ]
    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

  2. To explore the multimodal imaging technique for the diagnosis of gastrointestinal mucosal lesions [ Time Frame: 1 month ]
    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.


Biospecimen Retention:   Samples With DNA
Mucosal tissues or cells of gastritis, gastric cancer, intestinal polyps and colorectal cancer obtained by endoscopic biopsy or resection

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
People diagnosed or suspected of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, colorectal cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with cardiovascular and cerebrovascular diseases, or patients with severe impairment of liver, kidney and hematopoietic system
  2. Mental patients
  3. Hemorrhagic diseases
  4. Platelet count < 50 × 10 ^ 9 / L
  5. Allergic constitution
  6. unable to tolerate or cooperate with endoscopy
  7. Patients with serious complications, such as intestinal obstruction, intestinal perforation, toxic colonic dilatation, colorectal cancer, etc.
  8. Pregnant or lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196243


Contacts
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Contact: Yan Liu, MD +8613911798288 13911798288@163.com
Contact: Liang Wu, MD +8618110076598 wuliangdoc@163.com

Locations
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China, Beijing
The First Medical Center of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yan Liu    +8613911798288    13911798288@163.com   
Principal Investigator: Yan Liu         
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
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Principal Investigator: Yan Liu, MD Beijing 302 Hospital
More Information
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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT05196243    
Other Study ID Numbers: Multi-imaging
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
Mitochondrial DNA Mutation
Single cell sequencing
Molecular pathology
multimodal imaging
holography