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

NCT06550063 | Recruiting

• 1 other identifier: HERA001
• Study Type: observational
• Target: 2,188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Esophageal cancer; Gastric cancer; HER2-positive cancer; HER2-low cancer; Targeted treatment

Outcome Measures

Primary Outcomes (1)

• Geographical variation in HER2 status

  2000 - 2024

Secondary Outcomes (2)

• Clinical TNM stage

  2000 - 2024

• Overall survival

  2000 - 2024

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is a multi-center, retrospective, international cohort study including a population of patients diagnosed with EGA from 2000 to April 2024 across all stages of disease with primary tumour routinely tested for HER2 status.

You may qualify if:

• 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

You may not qualify if:

• \- Patients with esophageal squamous cell carcinoma

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead

Study Sites (1)

Trinity St James Cancer Institute

Dublin, Leinster, D08 NHY1, Ireland

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• John V Reynolds, MBBCh,MD

  Trinity St James Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola B Raftery, MBBCh,MSc

CONTACT

+353 86 1675454; rafteryn@tcd.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Dr

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: August 20, 2024
• Primary Completion: May 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

IE (1)