Profiling of Oncology Patients as Part of Clinical Care and Research

NCT03158636 | Completed DMC

• 1 other identifier: CTNZ-2016-01
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Utilisation rates of molecular profiling information.

  3 years

Secondary Outcomes (2)

• Number of patients where the molecular profiling information guided standard treatment or clinical trial enrollment.

  3 years

• Clinical trial accrual rates among patients with available molecular profiling data.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years.
• Histological diagnosis of gynaecological cancer OR diagnosis of cancer and candidate for phase I clinical trial
• ECOG performance status ≤2
• Life expectancy of greater than 3 month
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• \. Any contraindication to biopsy

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (1)

University of Auckland / Auckland City Hospital

Auckland, 1142, New Zealand

Location

Biospecimen

Retention: SAMPLES WITH DNA

Retrospective tissue collection. Circulating tumour DNA. Prospective tumour biopsies (where feasible).

Study Officials

• Michelle Wilson, MBChb, FRACP

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 18, 2017
• Study Start: September 1, 2016
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: to be confirmed
• Access Criteria: Deidentified patient data will be available for other research through applications to the governance committee of PROSPER. Applications will require ethics approval.

Locations

NZ (1)