Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000451505p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2024
Date registered
12/04/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
12/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
OMEGCA - Multi-Omics Evaluation of Peritoneal Fluid in Gastroesophageal Cancer
Scientific title
Multi-Omics Evaluation of Peritoneal Fluid in Gastroesophageal Cancer
Secondary ID [1] 310296 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OMEGCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal cancer 333107 0
Gastric adenocarcinoma 333108 0
Gastroesophageal junction adenocarcinoma 333109 0
Condition category
Condition code
Cancer 329793 329793 0 0
Stomach
Cancer 330011 330011 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 328112 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337560 0
2-year disease free survival (DFS) determined by review of medical records
Timepoint [1] 337560 0
2-years post diagnosis
Secondary outcome [1] 432324 0
Survival: 3-year peritoneal DFS as determined by review of medical records
Timepoint [1] 432324 0
3 years post diagnosis
Secondary outcome [2] 432325 0
Peritoneal lavage cytology status: present/absent/indeterminant as determined by review of medical results
Timepoint [2] 432325 0
Peritoneal washings will be collected at staging laparoscopy and surgical resection.
Secondary outcome [3] 432326 0
Imaging (CT/PET scans) and endoscopy: Location of disease recurrence
Timepoint [3] 432326 0
CT/PET scans will be completed for post operative follow up and again at one year and annually for 1-5 years post surgery.
Secondary outcome [4] 432327 0
Primary tumour histopathological features: T-stage, N-stage, grade, lymphovascular invasion, perineural infiltration, histological subtypes, tumour size, and tumour regression grading
(composite secondary outcome)
Timepoint [4] 432327 0
Tumour tissue and histopathology results will be obtained at staging laparoscopy.
Secondary outcome [5] 432328 0
Cost effectiveness: accounting for assay performance, direct-costs, technical aspects, clinical impact, and quality-adjusted life years.
Using data collected including admission and discharge dates, length of stay, clinical services provided to each episode of care (e.g. CT, PET, laparoscopy, chemotherapy, radiotherapy, surgery etc), outpatient follow-up, treating clinical units, estimated unit costs based on diagnosis-related group (DRG) and DRG descriptions, we will calculate the actual cost associated with each patient’s care along their cancer treatment journey.
Timepoint [5] 432328 0
Resource use determined at the end of the study
Secondary outcome [6] 432329 0
Genomic analysis of ptDNA: mutant allelic frequency thresholds, presence of actionable therapeutic targets against a registry of clinically proven and experimental therapies
(composite secondary outcome)
Timepoint [6] 432329 0
Peritoneal washings for ptDNA will be collected at staging laparoscopy and surgical resection.
Secondary outcome [7] 433207 0
ctDNA status: present/absent, mutant allelic frequency threshold
(Composite secondary outcomes)
Timepoint [7] 433207 0
Collection of blood for ctDNA will occur at staging laparscopy, surgical resection and post operative follow up
Secondary outcome [8] 433903 0
Survival: 3-year overall survival (OS) as determined by review of medical records
Timepoint [8] 433903 0
3 years post diagnosis
Secondary outcome [9] 433904 0
Survival: 5-year DFS, and 5-year OS as determined by review of medical records
Timepoint [9] 433904 0
5 years post diagnosis

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The clinical utility of ptDNA (ptDNA-positive vs ptDNA-negative), as determined by genomic and methylomic output, will be evaluated in consultation with our study biostatistician using the following metrics: sensitivity, specificity, positive-predictive value, negative-predictive value, receiver operator characteristics, Kaplan Meier and Cox regression, against the primary and secondary endpoints. Co-variates in these analyses will be accounted for using hierarchical multi-variate logistic regression algorithms.

Additionally, exploratory analyses will be performed to:
• Compare ptDNA detection rate before (at time of PLC) and after (at time of surgical resection) neoadjuvant therapy.
• Compare ptDNA versus circulating tumour DNA (i.e. plasma) to predict sites and patterns of disease recurrence.
• Compare the cost-effectiveness of genomic vs. methylomic approaches to detect ptDNA to inform translation into clinical practice.
• Curate and catalogue actionable molecular targets identified from whole exome sequencing of peritoneal wash fluid to inform future clinical trials.
These analyses will be performed using chi-square tests, Pearson correlations and other qualitative methodologies.

At a population level, this will be compared to a hypothetical projected cost based on whether ptDNA status changes clinical management, and whether this cost difference offsets the cost of a ptDNA assay. So for example: if ptDNA-positive status leads to treatment de-escalation, what would that cost (or cost saving) amount to if ptDNA becomes a standard test for all patients with gastroesophageal cancer?

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/06/2031
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 26222 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 26223 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 26224 0
The Northern Hospital - Epping
Recruitment hospital [4] 26226 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [5] 26227 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 26228 0
Western Hospital - Footscray - Footscray
Recruitment hospital [7] 26229 0
Eastern Health - Box Hill
Recruitment hospital [8] 26230 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 26231 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 26232 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 26233 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 42190 0
3000 - Melbourne
Recruitment postcode(s) [2] 42196 0
3011 - Footscray
Recruitment postcode(s) [3] 42195 0
3050 - Parkville
Recruitment postcode(s) [4] 42194 0
3065 - Fitzroy
Recruitment postcode(s) [5] 42192 0
3076 - Epping
Recruitment postcode(s) [6] 42191 0
3084 - Heidelberg
Recruitment postcode(s) [7] 42197 0
3128 - Box Hill
Recruitment postcode(s) [8] 42198 0
3168 - Clayton
Recruitment postcode(s) [9] 42200 0
5000 - Adelaide
Recruitment postcode(s) [10] 42201 0
5011 - Woodville
Recruitment postcode(s) [11] 42199 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 314507 0
Other Collaborative groups
Name [1] 314507 0
AGITG 2023 Innovation Grant
Country [1] 314507 0
Australia
Funding source category [2] 315980 0
Government body
Name [2] 315980 0
Victorian Cancer Agency
Country [2] 315980 0
Australia
Funding source category [3] 316745 0
Other Collaborative groups
Name [3] 316745 0
Australasian Gastro-Intestinal Trials Group (AGITG)
Country [3] 316745 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 316452 0
University
Name [1] 316452 0
Victorian Cancer Agendy Fellowship - Univeristy of Melbourne
Address [1] 316452 0
Country [1] 316452 0
Australia
Secondary sponsor category [2] 318954 0
Other Collaborative groups
Name [2] 318954 0
Australasian Gastro-Intestinal Trials Group (AGITG)
Address [2] 318954 0
Country [2] 318954 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313551 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 313551 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 313551 0
Australia
Date submitted for ethics approval [1] 313551 0
29/02/2024
Approval date [1] 313551 0
Ethics approval number [1] 313551 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128518 0
Dr David Liu
Address 128518 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, 3000 VIC
Country 128518 0
Australia
Phone 128518 0
+61 402 857 529
Fax 128518 0
Email 128518 0
david.liu@petermac.org
Contact person for public queries
Name 128519 0
David Liu
Address 128519 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, 3000 VIC
Country 128519 0
Australia
Phone 128519 0
+61 402 857 529
Fax 128519 0
Email 128519 0
david.liu@petermac.org
Contact person for scientific queries
Name 128520 0
David Liu
Address 128520 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, 3000 VIC
Country 128520 0
Australia
Phone 128520 0
+61 402 857 529
Fax 128520 0
Email 128520 0
david.liu@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This information will not be shared in accordance with ethics approval requirements.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.