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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03158636
Ethics application status
Date submitted
3/05/2017
Date registered
18/05/2017

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2024
Sample size
Target
Accrual to date
Final
37
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified patient data will be available for other research through applications to the governance committee of PROSPER. Applications will require ethics approval.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
to be confirmed
Available to whom?
Deidentified patient data will be available for other research through applications to the governance committee of PROSPER. Applications will require ethics approval.
Available for what types of analyses?
How or where can data be obtained?


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/NCT03158636