HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes

NCT ID: NCT06550063

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-20

Study Completion Date

2025-08-31

Brief Summary

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Targeted therapies offer promise to improve oncologic outcomes in esophagogastric adenocarcinoma (EGA). The landmark 'Trastuzumab for gastric cancer (ToGA)' trial established the therapeutic value of Human Epidermal Growth Factor Receptor 2 (HER2) directed therapy in advanced gastric and esophagogastric junction adenocarcinoma, setting a standard of care. Further studies, such as DESTINY-gastric01 and DESTINY-gastric02, have demonstrated the efficacy of antibody-drug conjugates (ADCs) targeting HER2-positive gastric and junctional tumours. The use of HER2-directed therapies in the curative intent setting has more recently been evaluated with favourable outcomes in phase II studies. However, data regarding the prevalence and prognostic significance of HER2 overexpression among patients undergoing treatment with curative intent are limited. Furthermore, few studies have evaluated the clinical significance of intratumoural and tumour-metastatic heterogeneity of HER2 expression, and the finding of HER2-low, in this context, which may have important implications for implementation of neoadjuvant targeted therapies in future. While limited single centre series have evaluated the clinicopathologic significance of HER2 status in EGA, no previous international multicentre study of this nature has been reported.

The goal of this international, multi-center, retrospective observational study is to elucidate the prevalence and clinical significance of HER2 expression in patients with EGA across different regions globally. The study also aims to assess the clinical significance of HER2 heterogeneity in a large, international cohort of patients with EGA, and its association with clinicopathological outcomes in patients with advanced and recurrent disease.

Detailed Description

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Conditions

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Esophagus Cancer Gastric Cancer HER2-positive Cancer HER2-low Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with newly diagnosed EGA from 2000 to April 2024 across all stages of disease
* Primary tumour HER2 status tested as routine in all patients with EGA
* Patients aged 18 years or over

Exclusion Criteria

\- Patients with esophageal squamous cell carcinoma
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. James's Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Nicola Raftery

Principal investigator, Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John V Reynolds, MBBCh,MD

Role: PRINCIPAL_INVESTIGATOR

Trinity St James Cancer Institute

Locations

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Trinity St James Cancer Institute

Dublin, Leinster, Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Nicola B Raftery, MBBCh,MSc

Role: CONTACT

+353 86 1675454

Facility Contacts

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Nicola B Raftery, MBBCh,MSc

Role: primary

+353 86 1675454

Other Identifiers

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HERA001

Identifier Type: -

Identifier Source: org_study_id

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