- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05196243
Multimodal Imaging Based on Pathological and Genomic Characteristics
20. marts 2022 opdateret af: Affiliated Hospital to Academy of Military Medical Sciences
A New Multimodal Imaging Technique Based on Pathological and Genomic Characteristics of Gastrointestinal Mucosa
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yan Liu, MD
- Telefonnummer: +8613911798288
- E-mail: 13911798288@163.com
Undersøgelse Kontakt Backup
- Navn: Liang Wu, MD
- Telefonnummer: +8618110076598
- E-mail: wuliangdoc@163.com
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100853
- Rekruttering
- The First Medical Center of Chinese PLA General Hospital
-
Kontakt:
- Yan Liu
- Telefonnummer: +8613911798288
- E-mail: 13911798288@163.com
-
Ledende efterforsker:
- Yan Liu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
People diagnosed or suspected of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, colorectal cancer
Beskrivelse
Inclusion Criteria:
- Diagnosis or suspected diagnosis of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, bowel cancer
- Written informed consent
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Study Group
Study on the genomic and molecular pathological characteristics of 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Single cell sequencing and identification of mitochondrial DNA variation in gastrointestinal lesions
Tidsramme: 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
|
1 month
|
|
To explore the multimodal imaging technique for the diagnosis of gastrointestinal mucosal lesions
Tidsramme: 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.
|
1 month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Yan Liu, MD, Beijing 302 Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. marts 2022
Primær færdiggørelse (Forventet)
1. juni 2022
Studieafslutning (Forventet)
1. juli 2024
Datoer for studieregistrering
Først indsendt
5. januar 2022
Først indsendt, der opfyldte QC-kriterier
5. januar 2022
Først opslået (Faktiske)
19. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Multi-imaging
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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