C16
Conditions
Interventions
Group 1: Serial measurements (10x) of circulating tumor DNA in blood samples during treatment and follow-up
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with GEJ/stomach adenocarcinoma scheduled for curative-intent treatment by perioperative chemo(radio)therapy and surgery 2. Ability of subject to understand character and individual consequences of the clinical trial 3. Age = 18 years 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Participation in an interventional trial with interference of procedures and/or outcome of this study 2. Patients with a legal guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is the evaluation of the prognostic value of serial ctDNA measurements in patients with GC/ACGEJ. Furthermore, the possibility to develop or adjust curative-intent treatment according to ctDNA results in these patients will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Detection rate of ctDNA (before start of cancer treatment) - ctDNA positivity at the respective time points - Disease-free survival defined as time from curative surgery until disease recurrence or death - Distant recurrence defined as disease recurrence after curative surgery at a different site than the primary tumor, e.g. liver, lung, peritoneal or bone metastases - Local recurrence defines as histologically proven recurrent tumor at the anastomosis or the perianastomotic region - Disease specific survival rate at two years after surgery defined as the percentage of patients, who have not died from GC/ACGEJ within two years of surgery. Patients, who died from other causes than GC/ACGEJ will not be counted in this measurement. | — |
Countries
Germany
Contacts
Public ContactFelix Hüttner
Universitätsklinikum Ulm, Klinik für Allgemein- und Viszeralchirurgie
Outcome results
None listed