Gastric CancerLIQUIDNCT04943406
Peritoneal Lavage Liquid Biopsy in Patients With Gastric Cancer
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastric Adenocarcinoma
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2020to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCSS Istituto Nazionale dei Tumori
Milan, 20133
Carlo Sposito, MD, 02-2390-3496 ext. +39, carlo.sposito@istitutotumori.mi.it
Carlo Sposito, MD
About this study
Official title: The Prognostic Performance of Liquid Biopsy in Peritoneal Lavage and Plasma of Patients With Locally Advanced Gastric Cancer (LIQUID Study)
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.
Read the detailed description
The purpose of this prospective observational study is to determine the prognostic role of liquid biopsy for the detection of circulating tumor DNA (ctDNA) in patients with locally advanced gastric cancer.
Patients with cT3-4 and or N+ gastric cancer will proceed to either staging laparoscopy, if preoperative chemotherapy is indicated, or upfront radical surgery within 2 weeks from the last imaging assessment.
Liquid biopsy will be performed with peritoneal lavage and blood samples. Peritoneal lavage is performed with 500 ml of saline, starting from the retrogastric space (100 ml) and following clockwise from right upper quadrant to right lower using 100 ml for each quadrant. At the end of peritoneal lavage, 250 ml of saline solution is collected over the liver, after having positioned the patient in Trendelenburg position and on the right side. Of the collected fluid, 50 mL will be sent for cytological examination and 50 mL will be stocked for ctDNA analyses.
In case of upfront radical surgery, liquid biopsy will be performed at the following time points:
- Through blood samples performed before skin incision and 7-10 days after radical surgery;
- Through peritoneal lavage, immediately after laparotomy/laparoscopy.
In case of staging laparoscopy, liquid biopsy will be performed with blood samples, just before skin incision, and with peritoneal lavage. Patients with no evidence of peritoneal dissemination after staging laparoscopy will undergo induction chemotherapy according to the FLOT scheme or per investigators' judgment, and restaged after 4 cycles. Patients still fulfilling the inclusion criteria will undergo radical surgery within 3 weeks from the last chemotherapy cycle. Patients will then undergo liquid biopsy with the same scheme as for upfront radical surgery.
Patients who are clinically fit, and for whom there is clinical indication, will undergo adjuvant chemotherapy. Blood samples for ctDNA will be collected at the end of the last cycle of adjuvant chemotherapy, or at the end of the third postoperative month for those patients not undergoing postoperative chemotherapy. Then, patients will be followed up according to standard protocols by means of CT scan, CEA assessment and clinical visit every six months for the first three years after surgery and then yearly up to five years after local treatments. Blood samples for ctDNA will be collected at detection of cancer recurrence.
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- liquid biopsy, gastric cancer, locally advanced gastric cancer, gastric adenocarcinoma
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At disease recurrence or at 3-year follow up
Secondary outcomes (5)
Rate of ctDNA positivity in peritoneal lavage and peripheral blood
To evaluate the rate of ctDNA positivity in peritoneal lavage and peripheral blood of patients with resectable, stage < IV, gastric cancer
Measured: 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
To evaluate the correlation between ctDNA detection and variables related to the clinical and histopathological characteristics of each patient
Measured: 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
To evaluate the dynamics of ctDNA detection in peritoneal lavage and peripheral blood in patients undergoing pre-operative chemotherapy at different time points
Measured: 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
To evaluate the dynamics of ctDNA detection in peripheral blood in patients undergoing pre-and post-operative chemotherapy, and at disease recurrence at different time points
Measured: 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
To evaluate the correlation between ctDNA positivity in peritoneal lavage and peripheral blood and the risk of developing peritoneal and distant metastases
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start8 May 2020
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Sposito, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Carlo Sposito, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943406
- Sponsor's protocol ID
- INT 55/20
- Acronym
- LIQUID
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18649106Allen 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.
PubMed 31612494Rossi 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.
PubMed 28099523Takahashi 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.
PubMed 30146098Normanno 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.
PubMed 30053724Mok 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.
PubMed 28514610Barault 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.
PubMed 28982739Diehl 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.
PubMed 18670422Pantel 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.
PubMed 30796368Tie 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.
PubMed 31621801Hamakawa 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.
PubMed 25490524Fang 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.
PubMed 26815009Gao 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.
PubMed 31850190Tsuchida 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.
PubMed 21953130
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Performance of Liquid Biopsy in Peritoneal Lavage and Plasma of Patients With Locally Advanced Gastric Cancer (LIQUID Study)
- ClinicalTrials.gov ID
- NCT04943406
- Acronym / sponsor ID
- LIQUID / INT 55/20
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- liquid biopsy, gastric cancer, locally advanced gastric cancer, gastric adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this prospective observational study is to determine the prognostic role of liquid biopsy for the detection of circulating tumor DNA (ctDNA) in patients with locally advanced gastric cancer.
Patients with cT3-4 and or N+ gastric cancer will proceed to either staging laparoscopy, if preoperative chemotherapy is indicated, or upfront radical surgery within 2 weeks from the last imaging assessment.
Liquid biopsy will be performed with peritoneal lavage and blood samples. Peritoneal lavage is performed with 500 ml of saline, starting from the retrogastric space (100 ml) and following clockwise from right upper quadrant to right lower using 100 ml for each quadrant. At the end of peritoneal lavage, 250 ml of saline solution is collected over the liver, after having positioned the patient in Trendelenburg position and on the right side. Of the collected fluid, 50 mL will be sent for cytological examination and 50 mL will be stocked for ctDNA analyses.
In case of upfront radical surgery, liquid biopsy will be performed at the following time points:
- Through blood samples performed before skin incision and 7-10 days after radical surgery;
- Through peritoneal lavage, immediately after laparotomy/laparoscopy.
In case of staging laparoscopy, liquid biopsy will be performed with blood samples, just before skin incision, and with peritoneal lavage. Patients with no evidence of peritoneal dissemination after staging laparoscopy will undergo induction chemotherapy according to the FLOT scheme or per investigators' judgment, and restaged after 4 cycles. Patients still fulfilling the inclusion criteria will undergo radical surgery within 3 weeks from the last chemotherapy cycle. Patients will then undergo liquid biopsy with the same scheme as for upfront radical surgery.
Patients who are clinically fit, and for whom there is clinical indication, will undergo adjuvant chemotherapy. Blood samples for ctDNA will be collected at the end of the last cycle of adjuvant chemotherapy, or at the end of the third postoperative month for those patients not undergoing postoperative chemotherapy. Then, patients will be followed up according to standard protocols by means of CT scan, CEA assessment and clinical visit every six months for the first three years after surgery and then yearly up to five years after local treatments. Blood samples for ctDNA will be collected at detection of cancer recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic impact of ctDNA positivity
Time frame: At disease recurrence or at 3-year follow up
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
5 secondary outcomes
Rate of ctDNA positivity in peritoneal lavage and peripheral blood
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 18649106Badgwell 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.
- Background: PubMed 31612494Allen 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.
- Background: PubMed 28099523Rossi 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.
- Background: PubMed 30146098Takahashi 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.
- Background: PubMed 30053724Normanno 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.
- Background: PubMed 28514610Mok 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.
- Background: PubMed 28982739Barault 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.
- Background: PubMed 18670422Diehl 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.
- Background: PubMed 30796368Pantel 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.
- Background: PubMed 31621801Tie 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.
- Background: PubMed 25490524Hamakawa 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.
- Background: PubMed 26815009Fang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Sposito, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Sposito, MD (02-2390-3496 ext. +39, carlo.sposito@istitutotumori.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic impact of ctDNA positivity (time frame: At disease recurrence or at 3-year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943406, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.