- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05196243
Multimodal Imaging Based on Pathological and Genomic Characteristics
20. mars 2022 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Forventet)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yan Liu, MD
- Telefonnummer: +8613911798288
- E-post: 13911798288@163.com
Studer Kontakt Backup
- Navn: Liang Wu, MD
- Telefonnummer: +8618110076598
- E-post: wuliangdoc@163.com
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100853
- Rekruttering
- The First Medical Center of Chinese PLA General Hospital
-
Ta kontakt med:
- Yan Liu
- Telefonnummer: +8613911798288
- E-post: 13911798288@163.com
-
Hovedetterforsker:
- Yan Liu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Yan Liu, MD, Beijing 302 Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. mars 2022
Primær fullføring (Forventet)
1. juni 2022
Studiet fullført (Forventet)
1. juli 2024
Datoer for studieregistrering
Først innsendt
5. januar 2022
Først innsendt som oppfylte QC-kriteriene
5. januar 2022
Først lagt ut (Faktiske)
19. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Multi-imaging
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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