Evaluation of ctDNA as a prognostic marker in gastric cancer or adenocarcinomas of the gastroesophageal junction - a prospective observational study
Recruiting
- Conditions
- C16Malignant neoplasm of stomach
- Registration Number
- DRKS00028259
- Lead Sponsor
- niversitätsklinikum Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
1. Participation in an interventional trial with interference of procedures and/or outcome of this study
2. Patients with a legal guardian
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Detection rate of ctDNA (before start of cancer treatment)<br>- ctDNA positivity at the respective time points<br>- Disease-free survival defined as time from curative surgery until disease recurrence or death<br>- 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<br>- Local recurrence defines as histologically proven recurrent tumor at the anastomosis or the perianastomotic region<br>- 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.