About this trial
Aneuploidy may be used as a more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques. Our aim is to establish whether aneuploidy as detected in cfDNA (as a measure for ctDNA) in PLF of patients with GC may hold value as an additional staging and tumor evaluation method in GC patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years old;
Written informed consent according to the ICH-GCP and national/local regula-tions.
Disqualifiers
Operable patients who will undergo a planned diagnostic laparoscopy for a benign indication bariatric or gallbladder disease);
Age ≥18 years old;
Written informed consent according to the ICH-GCP and national/local regulations.
Active inflammation or infection;
Trial population
Gastric cancer patients: Patients who will undergo DLS for GC or GEJ carcinoma Non-cancer controls: Operable patients who will undergo a planned diagnostic laparoscopy for a benign indication (bariatric or gallbladder disease);
Trial design
Cohort
Prospective
Treatments tested in this trial
collection additional peritoneal lavage fluid
Other interventioncollection additional peritoneal lavage fluid
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity mFast-SeqS
The primary endpoint is the sensitivity of the mFast-SeqS technique in patients with GC, and refers to the ability of the mFast-SeqS technique to correctly identify patients with the pres-ence of tumor cells in the peritoneal cavity.
Secondary outcomes
DFS
No locoregional or distant recurrence of disease,
Concordance detection rates peritoneal dissemination
• Concordance of detection rates of peritoneal dissemination will be analyzed using cohen's kappa/mcNemar's test
Sponsors and contacts
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