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LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer

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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
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Geoff Hall, University of Leeds

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Gynaecological Malignancy Other: Diagnostic analysis Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: Diagnostic Analysis
This arm will be subject to Caris Molecular profiling.
Other: Diagnostic analysis
Molecular profiling




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To analyse best response marker following CMI directed therapy [ Time Frame: 3 years ]
  2. 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 ]
  3. Study overall survival following CMI directed therapy. [ Time Frame: 3 years ]
  4. Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment. [ Time Frame: 3 years ]
  5. Assess cost of treatment with CMI versus originally planned treatment. [ Time Frame: 3 years ]
  6. To analyse quality adjusted life years (QALYs) in patients treated with CMI-directed therapy. [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02668913


Contacts
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Contact: Christopher Jones, BMedSc MB 01132068970 c.jones1@leeds.ac.uk
Contact: Clare Skinner, BSc 0113 343 4897 c.e.skinner@leeds.ac.uk

Locations
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United Kingdom
Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact: Christopher M Jones, MB ChB       c.jones1@leeds.ac.uk   
Sponsors and Collaborators
Geoff Hall
National Health Service, United Kingdom
Investigators
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Principal Investigator: Geoff Hall, PhD FRCP University of Leeds
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Responsible Party: Geoff Hall, Lead Clinical Investigator, University of Leeds
ClinicalTrials.gov Identifier: NCT02668913    
Other Study ID Numbers: MO15/302
15/YH/0493 ( Other Identifier: Yorkshire & Humber Ethics Committee )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Keywords provided by Geoff Hall, University of Leeds:
gynaecology
Oncology
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type