LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer

Study Overview
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Brief Summary
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This is a pilot feasibility study assessing the use of a commercial molecular profiling service in the UK's National Health Service (NHS). The impact of knowledge of a patient's molecular profile, and the time it takes to generate this knowledge, will be assessed by analysis of changes in physicians' treatment decisions prior to and following generation of a patient's molecular profile. Implications for benefit with therapies recommended by the profile will also be assessed and the following treatment outcomes collected: best response (based on routine clinical, radiological and biochemical assessment), progression free survival ratio (post Caris Molecular profiling versus prior treatment) and overall survival.

Detailed Description
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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.

Official Title
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LCC-CARIS-01: A Pilot Feasibility Study to Assess the Use of Molecular Profiling to Determine Choice of Treatment for Patients With Gynecological Cancer

Conditions
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Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Gynaecological Malignancy

Intervention / Treatment
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* Other: Diagnostic analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer OR patients with other gynaecological malignancy in whom the treating physician has made a decision to commence further systemic treatment with hormones or cytotoxic chemotherapy. Patient must be fit and willing to receive further treatment Plan to commence chemotherapy within 4 weeks of trial entry. Adequate tumour tissue, obtained within 36 months of study, must be available for molecular profiling. Age ≥ 18 years Patients who have fully understood the information provided and who have provided written informed consent. Patients for whom relevant pathology specimens are held by Leeds Teaching Hospitals Trust. Exclusion Criteria: Patients receiving treatment as part of a therapeutic trial in which physicians are not able to select any appropriate treatment option. Patients who lack capacity to consent to study participation. Patients with symptoms that mean it is clinically inappropriate to delay treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic Analysis<br>This arm will be subject to Caris Molecular profiling. | Other: Diagnostic analysis<br>* Molecular profiling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the number of treatment decisions that will be altered by the results of of the Caris molecular profiling report. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyse best response marker following CMI directed therapy |  | 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. |  | 3 years | 
| Study overall survival following CMI directed therapy. |  | 3 years | 
| Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment. |  | 3 years | 
| Assess cost of treatment with CMI versus originally planned treatment. |  | 3 years | 
| To analyse quality adjusted life years (QALYs) in patients treated with CMI-directed therapy. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gynaecology, Oncology