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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05063838




Registration number
NCT05063838
Ethics application status
Date submitted
6/09/2021
Date registered
1/10/2021
Date last updated
23/05/2023

Titles & IDs
Public title
Perioperative Pharmacogenomic Testing
Scientific title
Perioperative Pharmacogenomic Testing (PPGx) : A Feasibility and Randomised Controlled Pilot Study
Secondary ID [1] 0 0
PeterMac ID 20/85
Universal Trial Number (UTN)
Trial acronym
PPGx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacogenetics 0 0
Anesthesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pharmacogenomic optimisation of anaesthetic medications

Experimental: Pharmacogenomic group - The perioperative (anesthetic and postoperative pain management) plan for each patient will be determined preoperatively by the treating anesthesia team. Thereafter, the pharmacogenomic results of the patient will be released and a personalised anesthetic plan formulated based on international pharmacogenomic guidelines. The treating anesthesia team will then modify the perioperative care plan based on the patients' pharmacogenomic results and the international pharmacogenomic guidelines.

No Intervention: Control group - Perioperative care will be managed according to current 'standard care' practice at Peter MacCallum Cancer Centre.


Other interventions: Pharmacogenomic optimisation of anaesthetic medications
Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility - patient acceptability of pre-operative pharmacogenomic testing prior to their scheduled intermediate-major surgery.
Timepoint [1] 0 0
Pre-consent
Primary outcome [2] 0 0
Pilot RCT - post-operative pain control on day 1 after surgery
Timepoint [2] 0 0
Day 1
Secondary outcome [1] 0 0
Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability).
Timepoint [1] 0 0
Time of surgery
Secondary outcome [2] 0 0
Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.
Timepoint [2] 0 0
Prior to surgery
Secondary outcome [3] 0 0
Actionable genetic variations in our surgical population
Timepoint [3] 0 0
Intraoperative
Secondary outcome [4] 0 0
Frequency of change of drug prescribing based on pharmacogenomic testing
Timepoint [4] 0 0
72 hours
Secondary outcome [5] 0 0
Anesthesia team perceived benefit of modifying perioperative drug choice based on pharmacogenomic results (pharmacogenomic group)
Timepoint [5] 0 0
72 hours
Secondary outcome [6] 0 0
Post-operative pain and nausea and vomiting
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Quality of recovery during the postoperative period
Timepoint [7] 0 0
30 days
Secondary outcome [8] 0 0
Quality of recovery on day 1 postoperatively
Timepoint [8] 0 0
Day 1
Secondary outcome [9] 0 0
Post-operative pain as measured by total opioid dose
Timepoint [9] 0 0
72 hours
Secondary outcome [10] 0 0
Quality of life at post-operative day 30
Timepoint [10] 0 0
30 days

Eligibility
Key inclusion criteria
1. Able to provide written informed consent

2. Age greater than 18 years

3. Elective surgery scheduled greater than 1 week from preoperative assessment and date
of pharmacogenomic testing

4. Moderate-Major surgery expecting to last two or more hours with anticipated admission
of at least 1 night including: breast, melanoma, colorectal (laparoscopic or open),
prostate, or other major surgery (e.g. oesophagectomy, head and neck cancer,
retroperitoneal sarcoma, etc.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Day case surgery

2. Expected surgery duration of < 2 hours

3. Urgent surgery expected within 1 week of pre-operative assessment

4. Emergency surgery

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Adelaide
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a single centre, prospective feasibility study and pilot randomised controlled trial
of patients scheduled for elective intermediate or major non-cardiac surgery. The
investigators plan to randomise up to 200 patients who meet the inclusion criteria to
standard care or to personalised perioperative care based on pharmacogenomic testing for
drugs commonly used in anaesthesia and postoperative pain management e.g., opioids -
morphine, oxycodone and tramadol; anti-emetics - metoclopramide and ondansetron; and
non-steroidal drugs - celecoxib and ibuprofen.

The investigators hypothesise that pharmacogenomic testing is feasible prior to elective
surgery and through 'personalised prescribing' for precision tailored perioperative care the
investigators will improve patient's postoperative quality of recovery, including pain
management.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05063838
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle D Gerstman, MBBS, MD
Address 0 0
Country 0 0
Phone 0 0
+61 3 8559 7681
Fax 0 0
Email 0 0
michelle.gerstman@petermac.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05063838