Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
Scientific title
Perioperative Pharmacogenomic Testing (PPGx) : A Feasibility and Randomised Controlled Pilot Study
Query!
Secondary ID [1]
0
0
PeterMac ID 20/85
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PPGx
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pharmacogenetics
0
0
Query!
Anesthesia
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Feasibility - patient acceptability of pre-operative pharmacogenomic testing prior to their scheduled intermediate-major surgery.
Query!
Assessment method [1]
0
0
Percentage of eligible patients approached who consent to participate in the study (yes/no).
Query!
Timepoint [1]
0
0
Pre-consent
Query!
Primary outcome [2]
0
0
Pilot RCT - post-operative pain control on day 1 after surgery
Query!
Assessment method [2]
0
0
Pain on post-operative day 1 as measured by the Numerical Rating Scale (NRS)
Query!
Timepoint [2]
0
0
Day 1
Query!
Secondary outcome [1]
0
0
Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability).
Query!
Assessment method [1]
0
0
Percentage of patient test results available on day of surgery
Query!
Timepoint [1]
0
0
Time of surgery
Query!
Secondary outcome [2]
0
0
Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.
Query!
Assessment method [2]
0
0
Patient questionnaire regarding patient perceptions of pharmacogenomic testing
Query!
Timepoint [2]
0
0
Prior to surgery
Query!
Secondary outcome [3]
0
0
Actionable genetic variations in our surgical population
Query!
Assessment method [3]
0
0
Frequency of actionable variations as measured by pharmacogenomic testing
Query!
Timepoint [3]
0
0
Intraoperative
Query!
Secondary outcome [4]
0
0
Frequency of change of drug prescribing based on pharmacogenomic testing
Query!
Assessment method [4]
0
0
Number of changes during the intraoperative period and post-operative period (pharmacogenomic group).
Query!
Timepoint [4]
0
0
72 hours
Query!
Secondary outcome [5]
0
0
Anesthesia team perceived benefit of modifying perioperative drug choice based on pharmacogenomic results (pharmacogenomic group)
Query!
Assessment method [5]
0
0
Percentage of anesthetists who select "I found the pharmacogenomic results helpful in prescribing".
Query!
Timepoint [5]
0
0
72 hours
Query!
Secondary outcome [6]
0
0
Post-operative pain and nausea and vomiting
Query!
Assessment method [6]
0
0
Percentage recovery of the nociceptive domain of the PostopQRS™ scale between groups
Query!
Timepoint [6]
0
0
30 days
Query!
Secondary outcome [7]
0
0
Quality of recovery during the postoperative period
Query!
Assessment method [7]
0
0
Percentage recovery over time of all domains of the PostopQRS™.
Query!
Timepoint [7]
0
0
30 days
Query!
Secondary outcome [8]
0
0
Quality of recovery on day 1 postoperatively
Query!
Assessment method [8]
0
0
QoR-15
Query!
Timepoint [8]
0
0
Day 1
Query!
Secondary outcome [9]
0
0
Post-operative pain as measured by total opioid dose
Query!
Assessment method [9]
0
0
Total opioid dose used within the peri-operative period intra-operative, 0-24, 24-48 \& 48-72 hours after surgery.
Query!
Timepoint [9]
0
0
72 hours
Query!
Secondary outcome [10]
0
0
Quality of life at post-operative day 30
Query!
Assessment method [10]
0
0
EQ-5D-5L on POD-30 and Days alive at home within 30 days after surgery (DAH-30).
Query!
Timepoint [10]
0
0
30 days
Query!
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.)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/11/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/07/2024
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Peter MacCallum Cancer Centre, Australia
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
University of Adelaide
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05063838
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Michelle D Gerstman, MBBS, MD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 3 8559 7681
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05063838
Download to PDF