None listed
Conditions
Brief summary
The purpose of this study is to detect ptDNA using two different methods, and to determine if ptDNA can be used to provide information on the patient's cancer and chances of survival. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer of the gastroesophageal junction, the area where the esophagus and stomach join together. Study details We will recruit at least 200 patients with stomach and oesophageal cancer, and test their peritoneal washings, collected as part of routine staging, for ptDNA. We will also follow up all patients for 5 years after they are enrolled by collecting any relevant data from their medical records, specifically information on their cancer, possible cancer recurrence and survival. It is hoped that this study will produce a novel and accurate molecular test to detect microscopic peritoneal cancer deposits. This information will improve disease prognostication, facilitate patient counselling, inform clinical decision-making, and personalise cancer treatment to maximise benefit and reduce harm. If successful, this study will produce a novel and accurate molecular test to detect microscopic peritoneal cancer deposits. This information will improve disease prognostication, facilitate patient counselling, inform clinical decision-making, and personalise cancer treatment to maximise benefit and reduce harm.
Interventions
OMEGCA will be a prospective non-interventional and translational cohort study enrolling at least 200 patients with gastroesophageal cancer at hospitals across Victoria and South Australia. Patients who are undergoing routine peritoneal lavage cytology (PLC) and subsequent curative-intent treatment (either upfront surgery or perioperative systemic treatment and surgery) for gastroesophageal cancer will be recruited and the primary goal is to develop a molecular assay to enable accurate peritoneal staging in patients with gastroesophageal cancer. Tumour biopsies, blood and peritoneal lavage fluid will be collected during routine pre-treatment PLC for all patients. 20-30mL of peripheral blood samples will be taken at staging laparoscopy, surgical resection and post surgery in clinic. Tumour tissue (8-12 endoscopic biopies, 4 – 6 in normal saline and 4 – 6 in formalin) will be obtained along with normal stomach and oesophageal tissue (4 – 6 endoscopic biopsies in normal saline) at staging laparoscopy. Peritoneal fluid (15—250ml of 500ml 0.9% saline from 4 quadrants of peritoneal lavage) will be obtained at staging laparoscopy and surgical resection. Re-identifiable data including clinical data, CT and PET data, endoscopy data, histopathological detail and cost data will also be collected along with these samples. Clinical follow up for patients will involve a post operative follow up visit in clinic a post operative and where possible a blood sample will be collected for the purposes of this research. Clinical data obtained as part of routine care at this visit will also be contributed to this research and will be retrieved from medical records. Long term follow up will occur 1 – 5 years after surgery in clinic. Only data obtained for the purposes of routine surveillance will be required for this aspect of the research. Part of the samples obtained will undergo methylomic analysis at Peter MacCallum Cancer Centre, Victoria. The remaining biospecimens will undergo genomic whole exome sequencing analysis at the John Hospkins University Hospital and Haystack Oncology, USA. Both these methods are aimed at detecting the presence of tumour derived DNA in peritoneal fluid. Specifically, methylmoic analysis looks at the molecular markers that are present on the DNA molecule. How the DNA is uniquely marked may be a reflection of cancer specific. Whereas genomic sequencing looks for an error in the genetic code itself and that error is known as a variant. Participant recruitment will occur for 2 years with clinical follow up for 5 years after the last enrolled patient.
Sponsors
Eligibility
Inclusion criteria
1. All patients greater than 18 years-of-age at time of signing consent 2. Have a histologically confirmed diagnosis of one of the following: a. Gastric adenocarcinoma b. Gastroesophageal junction adenocarcinoma 3. Is undergoing staging laparoscopy and peritoneal lavage cytology 4. Provides informed consent
Exclusion criteria
1. Strictly oesophageal cancer 2. Distant organ disease on CT and PET/CT 3. Non-regional nodal disease on CT and PET/CT 4. Peritoneal carcinomatosis on CT and PET/CT 5. Performance status ECOG greater than or equal to 3 6. Undergoing emergency surgery 7. Non-curative/palliative-intent treatment