Gastric Cancer
Conditions
Keywords
peritoneal metastasis, cfDNA
Brief summary
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.
Detailed description
To ensure the appropriate treatment strategy for gastric cancer, various methods are employed to determine clinical disease stage. Peritoneal metastases are common in gastric cancer, but accurately detecting these peritoneal metastasis using conventional imaging techniques remains challenging. To increase the sensitivity of staging when gastric cancer appears resectable on CT imaging, a diagnostic peritoneal staging laparoscopy (DLS) is performed. During DLS, the abdominal cavity is inspected for the presence of macroscopic peritoneal metastasis. Furthermore, a peritoneal lavage with saline is performed, and the collected fluid is examined by a pathologist for the presence of cancer cells. However, the sensitivity of this cytological evaluation is limited, and as a result of false negative results, patients currently unjustly undergo treatment with curative intent, exposing them to the risks and side-effects of surgery and intensive perioperative chemotherapy. A more sensitive technique to detect peritoneal metastases during staging would lead to better personalized treatment; less toxic palliative treatment, or more intensive peritoneum-directed therapy in a trial setting in selected patients. A more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques may be the detection of ctDNA. One way to detect ctDNA is by assessing aneuploidy, as its presence reflects the fraction of circulating tumor DNA within cell-free DNA. Objective:To assess the value of ctDNA detection using aneuploidy analyses of peritoneal lavage fluid using mFAST-SeqS method in a prospective cohort of patients with gastric cancer who undergo a staging laparoscopy, in addition to the current staging methods (cytology, radiology, laparoscopy) and blood ctDNA analysis.
Interventions
OTHERcollection additional peritoneal lavage fluid
collection additional peritoneal lavage fluid
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Gastric cancer patients: Inclusion Criteria: * Age ≥18 years old; * Written informed consent according to the ICH-GCP and national/local regula-tions.
Exclusion criteria
\- Language difficulty, dementia or altered mental status prohibiting the under-standing and giving of informed consent. non-cancer controls: Inclusion criteria: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity mFast-SeqS | 4 years | 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
| Measure | Time frame | Description |
|---|---|---|
| DFS | 2 years | No locoregional or distant recurrence of disease, |
| Concordance detection rates peritoneal dissemination | 4 years | • Concordance of detection rates of peritoneal dissemination will be analyzed using cohen's kappa/mcNemar's test |
Countries
Netherlands
Contacts
CONTACTJessie Huizer, Drs.
CONTACTNiels Guchelaar
PRINCIPAL_INVESTIGATORBianca Mostert, MD
Erasmus Medical Center
PRINCIPAL_INVESTIGATORSjoerd Lagarde, MD
Erasmus Medical Center
Outcome results
None listed