Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308510
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-07
Brief Title:
Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
ObjectiveTo 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
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
ObjectiveTo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None