Clinical trial · Observational
Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer
NCT06308510CI-TRIAL-00086444recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| collection additional peritoneal lavage fluid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Gastric cancer patients
- description
- Operable patients who will undergo DLS for GC. Patients will be identified from the MDT (multidisciplinary tumor board).
- interventionNames
- Other: collection additional peritoneal lavage fluid
- label
- non-cancer controls
- description
- Patients who will undergo a planned laparoscopy for bariatric or gallbladder disease
- interventionNames
- Other: collection additional peritoneal lavage fluid
Primary outcomes (1)
- measure
- Sensitivity mFast-SeqS
- timeFrame
- 4 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.