Improving gastric cancer diagnosis using cell-free DNA analysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.