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Profiling of Oncology Patients as Part of Clinical Care and Research (PROSPER)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158636
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials New Zealand, University of Auckland, New Zealand

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.


Condition or disease
Gynecologic Cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Profiling of Oncology Patients as Part of Clinical Care and Research
Study Start Date : September 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021



Primary Outcome Measures :
  1. Utilisation rates of molecular profiling information. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Number of patients where the molecular profiling information guided standard treatment or clinical trial enrollment. [ Time Frame: 3 years ]
  2. Clinical trial accrual rates among patients with available molecular profiling data. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Retrospective tissue collection. Circulating tumour DNA. Prospective tumour biopsies (where feasible).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with gynaecological cancers or those patients potentially eligible for a phase I trial who are receiving cancer care under medical oncology at Auckland City Hospital will be approached to consider participation in this study. All patients who are over 18 and potentially eligible for further therapy (standard of care or as part of a clinical trial) will be considered.
Criteria

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.

Exclusion Criteria:

1. Any contraindication to biopsy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158636


Contacts
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Contact: Michelle Wilson, MBChb, FRACP +6499234927 mk.wilson@auckland.ac.nz
Contact: Lindsey Wylde, MSc(Res) +6499234927 l.wylde@auckland.ac.nz

Locations
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New Zealand
University of Auckland / Auckland City Hospital Recruiting
Auckland, New Zealand, 1142
Contact: Michelle Wilson, MBChb, FRACP    +64211561492    MiWilson@adhb.govt.nz   
Contact: Louise M Clement, MA    +6499234626    Louise.Clement@auckland.ac.nz   
Principal Investigator: Michelle Wilson, MBChb, FRACP         
Principal Investigator: Michael Findlay, MBChb, FRACP, MD         
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
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Principal Investigator: Michelle Wilson, MBChb, FRACP University of Auckland, New Zealand
Additional Information:

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Responsible Party: Cancer Trials New Zealand, Professor of Oncology, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT03158636    
Other Study ID Numbers: CTNZ-2016-01
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified patient data will be available for other research through applications to the governance committee of PROSPER. Applications will require ethics approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No