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LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer

Primary Purpose

Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Diagnostic analysis
Sponsored by
Geoff Hall
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epithelial Ovarian Cancer focused on measuring gynaecology, Oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Leeds Cancer Centre, Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic Analysis

Arm Description

This arm will be subject to Caris Molecular profiling.

Outcomes

Primary Outcome Measures

To measure the number of treatment decisions that will be altered by the results of of the Caris molecular profiling report.

Secondary Outcome Measures

To analyse best response marker following CMI directed therapy
Determine time to treatment failure (TTTF) (defined as the time from completion of prior therapy to start of next treatment) following CMI directed therapy.
Study overall survival following CMI directed therapy.
Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment.
Assess cost of treatment with CMI versus originally planned treatment.
To analyse quality adjusted life years (QALYs) in patients treated with CMI-directed therapy.

Full Information

First Posted
January 21, 2016
Last Updated
February 23, 2016
Sponsor
Geoff Hall
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02668913
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Geoff Hall
Collaborators
National Health Service, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Gynaecological Malignancy
Keywords
gynaecology, Oncology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Analysis
Arm Type
Experimental
Arm Description
This arm will be subject to Caris Molecular profiling.
Intervention Type
Other
Intervention Name(s)
Diagnostic analysis
Intervention Description
Molecular profiling
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To analyse best response marker following CMI directed therapy
Time Frame
3 years
Title
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
Title
Study overall survival following CMI directed therapy.
Time Frame
3 years
Title
Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment.
Time Frame
3 years
Title
Assess cost of treatment with CMI versus originally planned treatment.
Time Frame
3 years
Title
To analyse quality adjusted life years (QALYs) in patients treated with CMI-directed therapy.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Jones, BMedSc MB
Phone
01132068970
Email
c.jones1@leeds.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Skinner, BSc
Phone
0113 343 4897
Email
c.e.skinner@leeds.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoff Hall, PhD FRCP
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher M Jones, MB ChB
Email
c.jones1@leeds.ac.uk

12. IPD Sharing Statement

Learn more about this trial

LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer

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