Clinical trial · Observational
Peritoneal Lavage Liquid Biopsy in Patients With Gastric Cancer
The Prognostic Performance of Liquid Biopsy in Peritoneal Lavage and Plasma of Patients With Locally Advanced Gastric Cancer (LIQUID Study)
NCT04943406CI-TRIAL-00070280LIQUIDunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investigates the prognostic role of liquid biopsy in patients with locally advanced gastric cancer. Liquid biopsy for the detection of circulating tumor DNA will be performed: * In the peritoneal lavage, during staging laparoscopy (if indicated) and during curative gastrectomy * In plasma, before staging laparoscopy (if indicated), before curative gastrectomy, at hospital discharge, three months after surgery/at the end of adjuvant therapy, and in case of disease recurrence. The aim of this study is to determine the predictive power of liquid biopsy on overall survival and disease free survival.
Conditions
Conditions (2)
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 Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prognostic impact of ctDNA positivity
- timeFrame
- At disease recurrence or at 3-year follow up
- description
- To evaluate the prognostic impact (overall survival and disease-free survival) of ctDNA positivity in peritoneal lavage and peripheral blood of patients with resectable, stage \< IV, gastric cancer
Secondary outcomes (5)
- measure
- Rate of ctDNA positivity in peritoneal lavage and peripheral blood
- timeFrame
- Peritoneal lavage: at staging laparoscopy and at curative surgery; plasma: before staging laparoscopy, before curative surgery, at hospital discharge, 3 months after surgery/at the end of adjuvant therapy, at disease recurrence
- description
- To evaluate the rate of ctDNA positivity in peritoneal lavage and peripheral blood of patients with resectable, stage \< IV, gastric cancer
- measure
- Correlation between ctDNA detection and clinical and tumoral patients' characteristics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven gastric or gastro-esophageal junction (GEJ -Siewert type II -III) adenocarcinoma * More than cT2 and/or N + (UICC 8th edition) * Written informed consent Exclusion Criteria: * Presence of ascites or distant metastases * Previous chemotherapy for gastric adenocarcinoma * Previous gastric surgery * Absolute contraindications to surgery * Concomitant malignancies or history of other malignancies in the previous 5 years (with exception of in situ cervical carcinoma, basal cell carcinoma, superficial bladder tumors are allowed if curatively treated).
References
Publications (14)
- BACKGROUNDBadgwell B, Cormier JN, Krishnan S, Yao J, Staerkel GA, Lupo PJ, Pisters PW, Feig B, Mansfield P. Does neoadjuvant treatment for gastric cancer patients with positive peritoneal cytology at staging laparoscopy improve survival? Ann Surg Oncol. 2008 Oct;15(10):2684-91. doi: 10.1245/s10434-008-0055-3. Epub 2008 Jul 23. PMID 18649106
- BACKGROUNDAllen CJ, Newhook TE, Vreeland TJ, Das P, Minsky BD, Blum M, Song S, Ajani J, Ikoma N, Mansfield PF, Roy-Chowdhuri S, Badgwell BD. Yield of peritoneal cytology in staging patients with gastric and gastroesophageal cancer. J Surg Oncol. 2019 Dec;120(8):1350-1357. doi: 10.1002/jso.25729. Epub 2019 Oct 14. PMID 31612494
- BACKGROUNDRossi E, Bizzarro T, Martini M, Longatto-Filho A, Schmitt F, Fagotti A, Scambia G, Zannoni GF. The Role of Liquid Based Cytology and Ancillary Techniques in the Peritoneal Washing Analysis: Our Institutional Experience. PLoS One. 2017 Jan 18;12(1):e0168625. doi: 10.1371/journal.pone.0168625. eCollection 2017. PMID 28099523
- BACKGROUNDTakahashi H, Akita H, Wada H, Tomokuni A, Asukai K, Takahashi Y, Yanagimoto Y, Matsunaga T, Sugimura K, Yamamoto K, Nishimura J, Yasui M, Omori T, Miyata H, Yamamoto T, Nakanishi M, Shirayanagi M, Yamasaki T, Ohue M, Yano M, Sakon M, Ishikawa O. Subclinical cancer cell dissemination in peritoneal lavage fluid detected by reverse-transcription polymerase chain reaction identifies patients at high risk for peritoneal recurrence and consequent impaired survival in the setting of preoperative chemoradiation therapy for pancreatic cancer. Surgery. 2018 Dec;164(6):1168-1177. doi: 10.1016/j.surg.2018.06.047. Epub 2018 Aug 24. PMID 30146098
- BACKGROUNDNormanno N, Cervantes A, Ciardiello F, De Luca A, Pinto C. The liquid biopsy in the management of colorectal cancer patients: Current applications and future scenarios. Cancer Treat Rev. 2018 Nov;70:1-8. doi: 10.1016/j.ctrv.2018.07.007. Epub 2018 Jul 18. PMID 30053724
- BACKGROUNDMok TS, Wu YL, Papadimitrakopoulou VA. Osimertinib in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017 May 18;376(20):1993-4. doi: 10.1056/NEJMc1703339. No abstract available.