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OPPOSITE: Outcome Prediction of Systemic Treatment in Esophagogastric Carcinoma

NCT03429816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-27

No results posted yet for this study

Summary

Patients with locally advanced, resectable gastric or esophagogastric junction adenocarcinoma will receive a biopsy of the primary tumor, followed by standard-of care neoadjuvant systemic treatment; after neoadjuvant therapy tumor biopsies will be taken from different sites of the resection specimen.

* Aim 1: Organoid cultures of pre-treatment tumor biopsies will be established and exposed to the same chemotherapy as the corresponding patient; in vitro response to treatment will be correlated with the in vivo response of patients.
* Aim 2: Whole genome, methylome and RNA sequencing of tumors biopsies and organoids will be performed prior to as well as after systemic treatment. Histological and clinical outcome will be correlated with molecular subtypes.

Conditions

  • Gastric Neoplasm
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Esophageal Neoplasms

Interventions

PROCEDURE

Biopsy

Patients with locally advanced, resectable gastric or esophagogastric junction adenocarcinoma will receive a biopsy of the primary tumor, followed by standard-of care neoadjuvant systemic treatment; after neoadjuvant therapy tumor biopsies will be taken from different sites of the resection specimen.

Sponsors & Collaborators

  • University Hospital Dresden

    collaborator OTHER

  • German Cancer Research Center

    collaborator OTHER

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Georg Martin Haag · NCT, University Hospital Heidelberg

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2021-11-01
Completion
2023-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03429816 on ClinicalTrials.gov