Brief Title
LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer
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
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.
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
To measure the number of treatment decisions that will be altered by the results of of the Caris molecular profiling report.
Secondary Outcome
To analyse best response marker following CMI directed therapy
Condition
Epithelial Ovarian Cancer
Intervention
Diagnostic analysis
Study Arms / Comparison Groups
Diagnostic Analysis
Description: This arm will be subject to Caris Molecular profiling.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
72
Start Date
February 2016
Completion Date
October 2018
Primary Completion Date
October 2018
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Geoff Hall, PhD FRCP, 01132068970, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02668913
Organization ID
MO15/302
Secondary IDs
15/YH/0493
Responsible Party
Sponsor-Investigator
Study Sponsor
Geoff Hall
Collaborators
National Health Service, United Kingdom
Study Sponsor
Geoff Hall, PhD FRCP, Principal Investigator, University of Leeds
Verification Date
February 2016