- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07838415
Multimodalomics-based Construction of Spatiotemporal Characteristics of Dynamic Liver Cancer Microenvironment to Characterize the Clinical Application of Immune Mechanisms in Liver Cancer
This study aims to explore whether adding an additional MRI sequence to routine liver scans can better characterize the immune microenvironment of liver cancer. We plan to prospectively enroll patients diagnosed with or suspected of having liver cancer who undergo routine MRI examinations. In addition to the standard MRI protocol, participants will receive one extra MRI sequence. We will analyze the imaging features from this additional sequence and combine them with clinical data to construct a multi-omics model. The goal is to identify imaging biomarkers that can reflect the dynamic changes of the tumor microenvironment, which may help improve the diagnosis and clinical management of liver cancer.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: zhen li, PHD
- Telefonnummer: +86 130 3717 8109
- E-post: zhenli@hust.edu.cn
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430000
- Rekruttering
- Tongji Hospital
-
Ta kontakt med:
- Zhen li, PHD
- Telefonnummer: +86 130 3717 8109
- E-post: zhenli@hust.edu.cn
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Consecutive patients with suspected primary HCC detected on ultrasound or CT at our institution or referring hospitals were prospectively enrolled. All participants underwent EOB-MRI, including Td-dMRI and conventional sequences.
Beskrivelse
Inclusion Criteria:
- age 18 years or older, (b) pathologically confirmed HCC with available pathology slides, and (c) EOB-MRI including Td-dMRI within 1 month before surgery.
Exclusion Criteria:
- (a) lesions smaller than 1 cm, (b) poor imaging quality, and (c) received other treatments before surgery.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The primary outcomes of this study were PFS
Tidsramme: Up to 24 months after baseline MRI
|
PFS was calculated from the time of receiving treatment to disease progression or death, whichever occurred first, and progression was determined based on contrast-enhanced CT or MRI scans following mRECIST criteria |
Up to 24 months after baseline MRI
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TJ-IRB202412046
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Our institution maintains strict data security and patient privacy protection policies. Additionally, the sharing of clinical research data, particularly from studies involving human subjects, is subject to Chinese laws and regulations, including the Biosecurity Law and the Human Genetic Resources Management Regulations, which require institutional oversight and approval for any data transfer. We are committed to scientific transparency and are willing to share de-identified individual participant data upon reasonable request to the corresponding author, provided that such sharing is approved by our institutional review board and complies with all applicable laws and regulations.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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