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Spots Global Cancer Trial Database for Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer

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Trial Identification

Brief Title: Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer

Official Title: Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer

Study ID: NCT06308510

Conditions

Gastric Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Erasmus MC, Rotterdam, , Netherlands

Contact Details

Name: Bianca Mostert, MD

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Sjoerd Lagarde, MD

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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