Improving gastric cancer diagnosis using cell-free DNA analysis
Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer
This study is testing whether analyzing cell-free DNA from fluid in the abdomen can help doctors better detect advanced gastric cancer in patients and improve their treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06308510 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the detection of peritoneal metastasis in gastric cancer patients by analyzing aneuploidy in cell-free DNA (cfDNA) obtained from peritoneal lavage fluid. Conventional diagnostic methods, such as cytology and imaging, often yield false negatives, leading to inappropriate treatment strategies. By employing a more sensitive approach to identify circulating tumor DNA (ctDNA), the study seeks to improve staging accuracy and personalize treatment options for patients. The research involves collecting additional peritoneal lavage fluid during diagnostic laparoscopy to assess the presence of aneuploidy as a potential biomarker for metastasis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with gastric cancer who are undergoing diagnostic laparoscopy.
Not a fit: Patients with active inflammation, infection, or those with previous malignancies (unless in complete remission for at least 5 years) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate staging of gastric cancer, allowing for better-targeted treatments and reduced exposure to unnecessary surgical risks.
How similar studies have performed: While the use of cfDNA analysis is gaining traction, this specific application for gastric cancer staging is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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. Exclusion criteria: * Active inflammation or infection; * Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry (exceptions include but are not limited to, non-melanoma skin cancers; in situ bladder cancer, or in situ co-lon cancers; in situ cervical cancers/dysplasia; or breast carcinoma in situ).
Where this trial is running
Rotterdam
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Bianca Mostert, MD — Erasmus Medical Center
- Study coordinator: Jessie Huizer, Drs.
- Email: t.j.huizer@erasmusmc.nl
- Phone: +31107034523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.