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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03158636




Registration number
NCT03158636
Ethics application status
Date submitted
3/05/2017
Date registered
18/05/2017
Date last updated
18/04/2019

Titles & IDs
Public title
Profiling of Oncology Patients as Part of Clinical Care and Research
Scientific title
Profiling of Oncology Patients as Part of Clinical Care and Research
Secondary ID [1] 0 0
CTNZ-2016-01
Universal Trial Number (UTN)
Trial acronym
PROSPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynecologic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Utilisation rates of molecular profiling information.
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Number of patients where the molecular profiling information guided standard treatment or clinical trial enrollment.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Clinical trial accrual rates among patients with available molecular profiling data.
Timepoint [2] 0 0
3 years

Eligibility
Key inclusion criteria
1. Age =18 years.

2. Histological diagnosis of gynaecological cancer OR diagnosis of cancer and candidate
for phase I clinical trial

3. ECOG performance status =2

4. Life expectancy of greater than 3 month

5. Ability to understand and the willingness to sign a written informed consent document.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any contraindication to biopsy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The era of precision medicine is an exciting time for clinicians, scientists and patients
alike. The increasing appreciation and identification of specific mutations that drive
cancers, leaves us on the threshold of a new era in which biomarkers will be used to direct
targeted agents to only those patients most likely to respond. The potential medical and
scientific benefits of such a personalised approach to cancer therapy are immense. However, a
number of barriers challenge successful implementation of this approach of which spatial and
temporal heterogeneity are a major concern.

Gynaecological cancers are a major cause of mortality and morbidity internationally. In
Auckland 150 new patients with ovarian, endometrial or cervical cancer are seen by a medical
oncologist each year. In general, when these diseases recur, there are few effective
therapeutic options and prognosis is poor. Better therapeutic targets and treatments are an
unmet need across these tumour types with treatment paradigms still based upon platinum based
therapy.

PROSPER (Profiling of Oncology Patients as part of Clinical care and Research) will
investigate the evolution of gynaecological cancers over time and in response to treatment to
develop better biomarkers to guide treatment decisions and ultimately improve patient
outcomes. Biopsies at relapse will be collected and profiled with a 580 cancer gene panel.
Circulating tumour DNA will be collected and analysed alongside biopsies as a potential
non-invasive alternative. Linking genomic and clinical data will allow us to learn more to
begin to change our paradigm of care.
Trial website
https://clinicaltrials.gov/show/NCT03158636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michelle Wilson, MBChb, FRACP
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle Wilson, MBChb, FRACP
Address 0 0
Country 0 0
Phone 0 0
+6499234927
Fax 0 0
Email 0 0
mk.wilson@auckland.ac.nz
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03158636