NCT06550063 HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes
| NCT ID | NCT06550063 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. James's Hospital, Ireland |
| Condition | Esophagus Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,188 participants |
| Start Date | 2024-08-20 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,188 participants in total. It began in 2024-08-20 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
John V Reynolds, MBBCh,MD
PRINCIPAL INVESTIGATOR
Trinity St James Cancer Institute
Frequently Asked Questions
Who can join the NCT06550063 clinical trial?
This trial is open to participants of all sexes, studying Esophagus Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06550063 currently recruiting?
Yes, NCT06550063 is actively recruiting participants. Contact the research team at rafteryn@tcd.ie for enrollment information.
Where is the NCT06550063 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT06550063 clinical trial?
NCT06550063 is sponsored by St. James's Hospital, Ireland. The principal investigator is John V Reynolds, MBBCh,MD at Trinity St James Cancer Institute. The trial plans to enroll 2,188 participants.
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