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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • collection additional peritoneal lavage fluid

    Other intervention

    collection additional peritoneal lavage fluid

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: Gastric cancer patients1 intervention
Group B: non-cancer controls1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 years

Secondary outcomes

1

DFS

No locoregional or distant recurrence of disease,

Time frame
2 years
2

Concordance detection rates peritoneal dissemination

• Concordance of detection rates of peritoneal dissemination will be analyzed using cohen's kappa/mcNemar's test

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.