LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02668913|
Recruitment Status : Unknown
Verified February 2016 by Geoff Hall, University of Leeds.
Recruitment status was: Recruiting
First Posted : January 29, 2016
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Gynaecological Malignancy||Other: Diagnostic analysis||Phase 1 Phase 2|
The concept of molecular profiling leading to personalised medicine is based on the hypothesis that using treatments selected by a molecular profiling approach favourably changes the clinical course for an individual patient. In order to best determine the next steps in a particular patient's clinical course, it is necessary to understand not only how that patient has been diagnosed, treated and responded to treatment in the past, but also to fully characterize the molecular profile of the patient's tumour, so that the maximum information on potential positive and negative treatment outcome can be gathered.
In this pilot feasibility study, the treatment plans devised for individual patients by their treating oncologists will be assessed. The primary endpoint is the frequency at which the oncologist changes a treatment plan based on the tumour's molecular phenotype and the respective drugs considered to be associated with higher likelihood of benefit or lack of benefit. Ultimately however, the treatment decision remains in the hands of the treating physicians and the study protocol does not prescribe or dictate the use of any particular treatment.
In patients with recurrent ovarian cancer or other gynecological malignancies in which no standard of care is defined, treatments are currently chosen empirically based on population-based response rates. With the use of molecular profiling treating physicians will get a chance to revise their treatment plans and consider the individual molecular profile of each patient's tumour in light of the known predictive power of biomarkers for the efficacy of certain drugs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LCC-CARIS-01: A Pilot Feasibility Study to Assess the Use of Molecular Profiling to Determine Choice of Treatment for Patients With Gynecological Cancer|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Diagnostic Analysis
This arm will be subject to Caris Molecular profiling.
Other: Diagnostic analysis
- To measure the number of treatment decisions that will be altered by the results of of the Caris molecular profiling report. [ Time Frame: 21 days ]
- To analyse best response marker following CMI directed therapy [ Time Frame: 3 years ]
- Determine time to treatment failure (TTTF) (defined as the time from completion of prior therapy to start of next treatment) following CMI directed therapy. [ Time Frame: 3 years ]
- Study overall survival following CMI directed therapy. [ Time Frame: 3 years ]
- Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment. [ Time Frame: 3 years ]
- Assess cost of treatment with CMI versus originally planned treatment. [ Time Frame: 3 years ]
- To analyse quality adjusted life years (QALYs) in patients treated with CMI-directed therapy. [ Time Frame: 3 years ]
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): NCT02668913
|Contact: Christopher Jones, BMedSc MBemail@example.com|
|Contact: Clare Skinner, BSc||0113 343 firstname.lastname@example.org|
|Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS9 7TF|
|Contact: Christopher M Jones, MB ChB email@example.com|
|Principal Investigator:||Geoff Hall, PhD FRCP||University of Leeds|