Peritoneal Lavage Liquid Biopsy in Patients With Gastric Cancer

NCT04943406 | Unknown

• 1 other identifier: INT 55/20
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer; Gastric Adenocarcinoma

Keywords

liquid biopsy; gastric cancer; locally advanced gastric cancer; gastric adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Prognostic impact of ctDNA positivity

  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

  At disease recurrence or at 3-year follow up

Secondary Outcomes (5)

• Rate of ctDNA positivity in peritoneal lavage and peripheral blood

  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

• Correlation between ctDNA detection and clinical and tumoral patients' characteristics

  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

• Dynamics of ctDNA detection in peritoneal lavage and peripheral blood in patients undergoing pre-operative chemotherapy

  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

• Dynamics of ctDNA detection in peripheral blood in patients undergoing pre-and post-operative chemotherapy, and at disease recurrence

  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

• Prognostic impact of ctDNA positivity in peritoneal lavage and peripheral blood on the risk of peritoneal and distant metastases

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically proven gastric or GEJ Siewert type II and III adenocarcinoma with indication to either staging laparoscopy followed by perioperative chemotherapy and surgery with curative intent, or surgery with curative intent without perioperative treatment, will be included.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCSS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Related Publications (14)

• Badgwell 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 BACKGROUND

• Allen 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 BACKGROUND

• Rossi 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 BACKGROUND

• Takahashi 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 BACKGROUND

• Normanno 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 BACKGROUND

• Mok 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.

  PMID: 28514610 BACKGROUND

• Barault L, Amatu A, Siravegna G, Ponzetti A, Moran S, Cassingena A, Mussolin B, Falcomata C, Binder AM, Cristiano C, Oddo D, Guarrera S, Cancelliere C, Bustreo S, Bencardino K, Maden S, Vanzati A, Zavattari P, Matullo G, Truini M, Grady WM, Racca P, Michels KB, Siena S, Esteller M, Bardelli A, Sartore-Bianchi A, Di Nicolantonio F. Discovery of methylated circulating DNA biomarkers for comprehensive non-invasive monitoring of treatment response in metastatic colorectal cancer. Gut. 2018 Nov;67(11):1995-2005. doi: 10.1136/gutjnl-2016-313372. Epub 2017 Oct 5.

  PMID: 28982739 BACKGROUND

• Diehl F, Schmidt K, Choti MA, Romans K, Goodman S, Li M, Thornton K, Agrawal N, Sokoll L, Szabo SA, Kinzler KW, Vogelstein B, Diaz LA Jr. Circulating mutant DNA to assess tumor dynamics. Nat Med. 2008 Sep;14(9):985-90. doi: 10.1038/nm.1789. Epub 2007 Jul 31.

  PMID: 18670422 BACKGROUND

• Pantel K, Alix-Panabieres C. Liquid biopsy and minimal residual disease - latest advances and implications for cure. Nat Rev Clin Oncol. 2019 Jul;16(7):409-424. doi: 10.1038/s41571-019-0187-3.

  PMID: 30796368 BACKGROUND

• Tie J, Cohen JD, Wang Y, Christie M, Simons K, Lee M, Wong R, Kosmider S, Ananda S, McKendrick J, Lee B, Cho JH, Faragher I, Jones IT, Ptak J, Schaeffer MJ, Silliman N, Dobbyn L, Li L, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer. JAMA Oncol. 2019 Dec 1;5(12):1710-1717. doi: 10.1001/jamaoncol.2019.3616.

  PMID: 31621801 BACKGROUND

• Hamakawa T, Kukita Y, Kurokawa Y, Miyazaki Y, Takahashi T, Yamasaki M, Miyata H, Nakajima K, Taniguchi K, Takiguchi S, Mori M, Doki Y, Kato K. Monitoring gastric cancer progression with circulating tumour DNA. Br J Cancer. 2015 Jan 20;112(2):352-6. doi: 10.1038/bjc.2014.609. Epub 2014 Dec 9.

  PMID: 25490524 BACKGROUND

• Fang WL, Lan YT, Huang KH, Liu CA, Hung YP, Lin CH, Jhang FY, Chang SC, Chen MH, Chao Y, Lin WC, Lo SS, Fen-Yau Li A, Wu CW, Chiou SH, Shyr YM. Clinical significance of circulating plasma DNA in gastric cancer. Int J Cancer. 2016 Jun 15;138(12):2974-83. doi: 10.1002/ijc.30018. Epub 2016 Feb 18.

  PMID: 26815009 BACKGROUND

• Gao Y, Xi H, Wei B, Cui J, Zhang K, Li H, Cai A, Shen W, Li J, Rosell R, Chao J, Chen T, Klempner S, Qiao Z, Chen L. Association Between Liquid Biopsy and Prognosis of Gastric Cancer Patients: A Systematic Review and Meta-Analysis. Front Oncol. 2019 Nov 26;9:1222. doi: 10.3389/fonc.2019.01222. eCollection 2019.

  PMID: 31850190 BACKGROUND

• Tsuchida K, Yoshikawa T, Tsuburaya A, Cho H, Kobayashi O. Indications for staging laparoscopy in clinical T4M0 gastric cancer. World J Surg. 2011 Dec;35(12):2703-9. doi: 10.1007/s00268-011-1290-5.

  PMID: 21953130 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Liquid biopsy for the detection of circulating tumor DNA obtained from peritoneal lavage and plasma

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Carlo Sposito, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Sposito, MD

CONTACT

02-2390-3496; carlo.sposito@istitutotumori.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: May 8, 2020
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)