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Alternative Splicing Based Prediction of Chemotherapy Response in Gastric Cancer

8. maj 2026 opdateret af: City of Hope Medical Center

A Multicenter Observational Study to Develop and Validate an Alternative Splicing-Based Machine Learning Model for Predicting Response to 5-FU-Based Adjuvant Chemotherapy in Gastric Cancer (VERSA-GC Study)

This study aims to develop a model to predict response to chemotherapy in gastric cancer using RNA splicing information from tumor tissue.

By analyzing genetic patterns and applying machine learning, the study seeks to identify patients who are less likely to benefit from treatment, helping guide clinical decision-making.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This multicenter observational study aims to develop and validate an alternative splicing (AS)-based model to predict response to 5-FU-based adjuvant chemotherapy in stage II/III gastric cancer.

AS events were identified using TCGA SpliceSeq and UCSC Xena data, and selected candidates were quantified by RT-qPCR.

A predictive model was constructed using Elastic Net-based feature selection and XGBoost, and evaluated in independent training and validation cohorts. An integrated model incorporating clinicopathological factors was also developed.

The primary endpoint is treatment response defined by 3-year recurrence-free survival. Patients with recurrence within 3 years are classified as non-responders, and those without recurrence as responders.

This study aims to establish a clinically applicable biomarker for risk stratification and treatment decision support.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

329

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91016
        • Rekruttering
        • City of Hope Medical Center

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with stage II and III gastric cancer who underwent curative resection and received 5-FU-based adjuvant chemotherapy across multiple institutions.

Beskrivelse

Inclusion Criteria:

  • Pathologically confirmed stage II or III gastric cancer
  • Underwent curative surgical resection
  • Received 5-FU-based adjuvant chemotherapy
  • Availability of tumor tissue samples for analysis

Exclusion Criteria:

  • History of other malignancies
  • Inadequate or poor-quality tissue samples (e.g., contamination)

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
Responder
Patients with stage II/III gastric cancer who did not develop recurrence within 3 years after curative surgery following adjuvant chemotherapy.
Andet: Observational study (no intervention)
This is an observational study without assigned interventions. All patients received standard-of-care 5-FU-based adjuvant chemotherapy, and no experimental intervention was performed.
Non-responder
Patients with stage II/III gastric cancer who developed recurrence within 3 years after curative surgery following adjuvant chemotherapy.
Andet: Observational study (no intervention)
This is an observational study without assigned interventions. All patients received standard-of-care 5-FU-based adjuvant chemotherapy, and no experimental intervention was performed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment response based on 3-year recurrence-free survival
Tidsramme: 3 years after surgery
Treatment response was defined based on recurrence-free survival (RFS). Patients who developed recurrence within 3 years after curative surgery were classified as non-responders, whereas those without recurrence were classified as responders.
3 years after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic performance of the predictive model
Tidsramme: At model evaluation
Model performance was assessed using the area under the receiver operating characteristic curve, sensitivity, and specificity in the training and validation cohorts.
At model evaluation
Recurrence-free survival stratified by predefined model-derived risk score
Tidsramme: Up to 5 years after surgery
Recurrence-free survival will be evaluated according to the predefined model-derived risk score using Kaplan-Meier survival analysis and Cox proportional hazards models. Recurrence status within 3 years after surgery will be used to define treatment response.
Up to 5 years after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

City of Hope Medical Center

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. maj 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 23228/VERSA

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Mavekræft

Kliniske forsøg med Observational study (no intervention)

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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