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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/NCT03158636
Registration number
NCT03158636
Ethics application status
Date submitted
3/05/2017
Date registered
18/05/2017
Date last updated
16/05/2024
Titles & IDs
Public title
Profiling of Oncology Patients as Part of Clinical Care and Research
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Scientific title
Profiling of Oncology Patients as Part of Clinical Care and Research
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Secondary ID [1]
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CTNZ-2016-01
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Universal Trial Number (UTN)
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Trial acronym
PROSPER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gynecologic Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Utilisation rates of molecular profiling information.
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Number of patients where the molecular profiling information guided standard treatment or clinical trial enrollment.
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Clinical trial accrual rates among patients with available molecular profiling data.
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Assessment method [2]
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Timepoint [2]
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3 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any contraindication to biopsy
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/05/2024
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Sample size
Target
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03158636
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michelle Wilson, MBChb, FRACP
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Address
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University of Auckland, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03158636
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