Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000365763
Ethics application status
Approved
Date submitted
28/01/2022
Date registered
1/03/2022
Date last updated
1/03/2022
Date data sharing statement initially provided
1/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of NSW Early Clinical Trials Alliance Network Assistance in Cancer Trials Access
Scientific title
Practical Assessment of NSW Early Clinical Trials Alliance (NECTA) Network Assistance in Cancer Outpatient Trials Access for patients with advanced or refractory cancer
Secondary ID [1] 306306 0
None
Universal Trial Number (UTN)
Trial acronym
PANNA-COTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 325064 0
Condition category
Condition code
Cancer 322499 322499 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with advanced/refractory cancer will be referred for access and enrolment to clinical trials in New South Wales through the NSW Early Clinical Trials Alliance (NECTA) network. The study will determine the benefits of genomic profiling in a subset of patients referred for early phase clinical trials to NECTA using a ctDNA assay.
1. Patients will be asked to provide initial informed consent to collect information and perform other screening procedures for consideration of early phase clinical trial across the trial sites as well as consideration for the ctDNA assay (if they have an eligible tumour type)
2. Oncology Clinician confirms eligibility and ECOG status within 7 days prior to consent.
3. Follow up patient status does not require a patient visit; data will be collected from medical records or linkage with other databases

Details of Assessments
1. Informed patient consent - prior to enrolment
Informed patient consent will be obtained to participate in the study and to perform the ctDNA assay where eligible.
2. Clinician referral of patient - at time point of enrolment
A baseline core clinical dataset will be captured on all patients referred to the NECTA network who intend on undergoing genomic profiling to ensure patients meet the eligibility criteria. Patient status including stage and type of tumour, disease status and previous line of treatments will be recorded. The information will be entered into a secure database/paper or electronic record managed by NECTA and by the individual sites that patients are being recruited from.
3. Retrieval of archival biospecimens - at time point of enrolment
Optional consent will be requested for retrieval of archival tumour tissue samples where available for future, unspecified research including genomics, transcriptomics and proteomics assays.
4. Biospecimen collection and processing - within 7 days of enrolment
ctDNA Assay:
A sample of peripheral blood (10 mLs, in 2 test tubes) will be obtained from each participant who consent to PANNA-COTA and are eligible for the assay within 7 days of trial enrolment. The blood sample will be sent to a central laboratory for testing.
5. Clinical assessment including previous lines of treatment - within 2 weeks following enrolment
A core clinical dataset will be collected on all patients including Patient’s ECOG Status, comorbidities, stage and tumour type, previous lines of treatment and their response to those treatment will be recorded.
6. Tumour Board (TB) review and recommendation - within 4 weeks following enrolment
Referring oncologists will obtain the ctDNA report result and be able to make Phase 1 trial recommendations upon receipt of the result, if there is a suitable trial available to that clinician. If there is no suitable trial, the results will be discussed at the Tumour Board which will meet on a fortnightly basis. Individual patient screening results will be presented in conjunction with an overview of the patient's clinical information. Genomic results, clinical information and their demographics will be reviewed by oncologists and considered when determining individual clinical trial recommendations across the NECTA network. The TB report will be provided to the patients’ referring clinician and trials team.
7. Questionnaires - within 8 weeks of enrolment
Psychosocial questionnaires and interviews
Questionnaires will be used to evaluate clinicians’ understanding and expectations of clinical trial enrolment and impact of ctDNA results will be collected at study registration (into screening phase) and additional time points after return of screening.
A questionnaire will be used to evaluate patients’ understanding and expectations of clinical trial enrolment and impact of ctDNA results and will be collected following prospective trial enrolment.
8. Follow up - beginning immediately post enrolment and up to 2 years following enrolment
Patient will be requested to allow their ongoing health status to be periodically reviewed via continued study visits or phone contact or from their general practitioner, or medical records, state-based cancer registries and/or the national mortality registry (AIHW).

Participants may be referred back to the Tumour Board for further recommendations if they are unable to be enrolled in initial trial options or treatment is unsuccessful. There is no set waiting or washout period as part of this study.
Intervention code [1] 322735 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330290 0
To determine the time to phase 1 trial enrolment in patients accessing the NECTA Network .
Time to phase 1 trial enrolment is the time in days from when a patient is seen by a Phase 1 oncologist, for consideration of early phase clinical trials at a site, to the time the patient signs consent for enrolment on a clinical trial.
Data will be collected based on date of patient consultation by oncologist as entered in the study referral form and based on patient enrolment outcome in a trial as reported in the follow up questionnaire by the trial oncologist.
Timepoint [1] 330290 0
The time from patient consultation to enrolment in a phase 1 clinical trial will be assessed based on collected data following the reporting of each patient's enrolment status in a clinical trial. All patient outcomes will be collated and analysed following completion of the study.
Secondary outcome [1] 405593 0
To assess the impact of information from a ctDNA assay on oncologists’ confidence in making Phase 1 trial recommendations for patients on a custom-designed survey (Likert scale).
Data will be collected by each referring oncologist completion of a questionnaire.
Timepoint [1] 405593 0
All oncologist questionnaires will be assessed following completion of the study.
Secondary outcome [2] 406059 0
To assess the impact of information from a ctDNA assay on patients’ confidence 0n potential trial options. This data will be collected via a patient questionnaire provided to them by trial oncologists using a customised Likert scale item designed for this study.
Timepoint [2] 406059 0
The patient questionnaires will be assessed following all patient's completion of the forms.

Eligibility
Key inclusion criteria
Criteria for general study enrolment:
1. Patients with any advanced solid tumour who have completed/failed standard treatment for their condition will be eligible for this study.
2. Age > 18 years.
3. Willing to consider participation in an early phase clinical trial available at at least one other NECTA institution, including traveling and/or remote management.
4. Eastern Cooperative Oncology Group Performance Status of 0-1
5. Suitable for a phase 1 clinical trial based on physician opinion incorporating haematologic, biochemical and symptomatic assessments, suggested parameters include;
• Neutrophils (absolute neutrophil count ANC >1.5X10^9/L,)
• Hemoglobin 9 g/dL
• Platelet count 90,000/microlitre
• Serum albumin2.8 g/dL
• Total bilirubin 1.5 the upper limit of normal (ULN) and AST and ALT 2.5 XULN, with the following exceptions:
o Patients with known Gilbert syndrome who have serum bilirubin 3XULN may be enrolled.
o Patients with documented liver metastasis may have AST and ALT 5XULN
• PTT (or aPTT) and INR 1.5XULN (except for patients receiving anticoagulation therapy)
• Serum creatinine 1.5XULN or creatinine clearance 50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation: (140 - age) X(weight in kg) X0.85 (if female) 72 X(serum creatinine in mg/dL)
6. Life expectancy of at least 3 months
7. Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1, or RANO or PCWG3 criteria. Ovarian cancer patients without any measurable disease may be enrolled on the basis of CA 125 elevation as per GCIG Criteria. ( greater then twice the upper limit of normal ). Other patients can be enrolled on a case-by-case basis in discussion with the study site PI.
8. Patients who have had previous comprehensive tumour NGS molecular testing (> 6 months prior to enrolment with at least one line of therapy after tumour NGS testing) will also be eligible.
9. Willing and able to comply with all study assessments

Additional criteria for collection of participants' ctDNA samples:
1. Willing to provide a blood sample for the ctDNA assay
2. Patients who have had previous hotspot molecular testing are also eligible for ctDNA testing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with any other prior malignancy from which the patient has been disease free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer as approved by study site PI.
2. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic or asymptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study or follow up requirements.
3. Patients with symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study. Patients with untreated stable or asymptomatic brain metastases may be enrolled on a case-by-case basis in discussion with study site PI.
4. Patients with psychiatric illness/social situations that would limit compliance with study requirements


Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310653 0
Hospital
Name [1] 310653 0
St Vincent's Hospital Sydney
Country [1] 310653 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
370 Victoria Street, Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 311862 0
Hospital
Name [1] 311862 0
Chris O'Brien Lifehouse
Address [1] 311862 0
119-143 Missenden Rd, Camperdown NSW 2050
Country [1] 311862 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310247 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 310247 0
Ethics committee country [1] 310247 0
Australia
Date submitted for ethics approval [1] 310247 0
Approval date [1] 310247 0
22/12/2021
Ethics approval number [1] 310247 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116994 0
Dr Jia Liu
Address 116994 0
St Vincent's Hospital Sydney
370 Victoria St, Darlinghurst NSW 2010
Country 116994 0
Australia
Phone 116994 0
+61 2 9355 5600
Fax 116994 0
Email 116994 0
[email protected]
Contact person for public queries
Name 116995 0
Max Farrow
Address 116995 0
NSW Early Clinical Trials Alliance
384 Victoria St, Darlinghurst NSW 2010
Country 116995 0
Australia
Phone 116995 0
+61 2 9295 8100
Fax 116995 0
Email 116995 0
[email protected]
Contact person for scientific queries
Name 116996 0
Max Farrow
Address 116996 0
NSW Early Clinical Trials Alliance
384 Victoria St, Darlinghurst NSW 2010
Country 116996 0
Australia
Phone 116996 0
+61 2 9295 8100
Fax 116996 0
Email 116996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.