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Correlation and Heterogeneity of the Immune Microenvironment and Histopathological Growth Patterns in Resectable Colorectal Cancer Liver Metastases (CRLM)

27. april 2026 opdateret af: Meng Qiu
Correlation and Heterogeneity of the Immune Microenvironment and Histopathological Growth Patterns in Resectable Colorectal Cancer Liver Metastases

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study aims to retrospectively analyze the status and spatial heterogeneity of the tumor microenvironment (TME) in liver metastases from patients with CRLM, as well as the association between HGPs at the tumor-liver interface and postoperative recurrence following resection of liver metastases. Furthermore, this study seeks to explore the underlying mechanisms through which HGPs influence patient prognosis.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

64

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital of Sichuan University

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This study enrolled patients with CRLM who underwent R0 resection.

Beskrivelse

Inclusion Criteria:

  • Patients with CRLM who underwent R0 resection
  • Histologically or cytologically confirmed CRLM
  • Have sufficient liver metastasis tissue specimens available for analysis
  • Complete treatment and follow-up records

Exclusion Criteria:

  • Patients did not undergo R0 resection
  • Postoperative specimens were unavailable
  • Clinical data were incomplete.

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
patients with CRLM who underwent R0 resection
According to the 2017 guidelines on histopathological growth patterns of liver metastases, HGPs are primarily classified into three types: the desmoplastic histopathological growth pattern (dHGP), the replacement histopathological growth pattern (rHGP), and the pushing histopathological growth pattern (pHGP). The tumor-liver interface was independently delineated by two pathologists using QuPath software, and distinct HGPs at the tumor-liver interface were identified. Formalin-fixed, paraffin-embedded (FFPE) sections of colorectal cancer liver metastases were stained with hematoxylin and eosin (H&E).Multiplex immunohistochemistry (mIHC) staining was performed on FFPE sections of liver metastases using two panels (Panel 1: CD4, CD8A, Foxp3, PD-L1, Panck; Panel 2: CD68, CD163, FAP-α, α-SMA, Panck), encompassing a total of nine immune cell markers.
Andet: Formalin-fixed, paraffin-embedded (FFPE) sections of colorectal cancer liver metastases were stained with hematoxylin and eosin (H&E) and Multiplex immunohistochemistry (mIHC) staining.
Formalin-fixed, paraffin-embedded (FFPE) sections of colorectal cancer liver metastases were stained with hematoxylin and eosin (H&E) and Multiplex immunohistochemistry (mIHC) staining.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
OS(Overall survival)
Tidsramme: OS is defined as the time from the date of the first liver metastasis resection to death due to any cause or loss to follow-up, assessed up to 100 months.
OS was defined as the time from the date of the first liver metastasis resection to death due to any cause or loss to follow-up.
OS is defined as the time from the date of the first liver metastasis resection to death due to any cause or loss to follow-up, assessed up to 100 months.
RFS (Recurrence-free Survival)
Tidsramme: From the date of liver resection until the first occurrence of a measurable recurrence of the disease, or until death due to any cause (whichever occurs first), the assessment period can be up to 100 months.
The definition of recurrence-free survival is the time from the liver surgery to the first imaging evidence showing disease recurrence or death due to any cause, whichever occurs first.
From the date of liver resection until the first occurrence of a measurable recurrence of the disease, or until death due to any cause (whichever occurs first), the assessment period can be up to 100 months.
HGPs (Histopathological Growth Patterns)
Tidsramme: From the completion of HE staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.
The histopathological growth pattern of the tumor-liver interface.
From the completion of HE staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.
TME (Tumor Microenvironment)
Tidsramme: From the completion of mIHC staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.
Multiplex immunohistochemistry (mIHC) staining was performed on FFPE sections of liver metastases using two panels (Panel 1: CD4, CD8A, Foxp3, PD-L1, Panck; Panel 2: CD68, CD163, FAP-α, α-SMA, Panck), encompassing a total of nine immune cell markers. Using QuPath pathology imaging software, tissue sections were divided into the tumor center (defined as regions >500 μm from the liver-tumor interface) and the invasive tumor front (defined as a 1 mm region extending 500 μm on either side of the liver-tumor interface). Quantitative analysis of immune cell populations was performed in the tumor center, the invasive tumor front, and regions corresponding to different histopathological growth patterns.
From the completion of mIHC staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Meng Qiu

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

1. januar 2018

Primær færdiggørelse (Anslået)

30. december 2030

Studieafslutning (Anslået)

30. december 2030

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Approval No. 2021, 2024

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

First of all, there is a lack of sufficient funds or personnel to anonymize and maintain the data for a long time, such as the original imaging documents, which are difficult to organize compliance. Second, this study was an early exploratory study with small data size and high risk of identification. Finally, summary results are available after publication, and the data will be reassessed 5 years after the end of the study.

Studiedata/dokumenter

  1. Statistisk analyseplan
    Informations-id: qiumeng@wchscu.cn
    Oplysningskommentarer: Survival analysis was estimated using the Kaplan-Meier method and compared using the log-rank test. Quantitative data regarding the immune microenvironment were compared using the t-test or the Mann-Whitney U test, as appropriate. Changes between initial resection and secondary resection were analyzed using the nonparametric test for two paired samples. The endpoints of this study included patient clinical outcomes (OS and PFS), spatial distribution differences of immune cells within TME of liver metastases, distribution patterns of HGPs and their correlation with survival, and analysis of the immune microenvironment in relation to HGPs.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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