LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer

February 23, 2016 updated by: Geoff Hall

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geoff Hall

Collaborators

National Health Service, United Kingdom

Investigators

  • Principal Investigator: Geoff Hall, PhD FRCP, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO15/302
  • 15/YH/0493 (Other Identifier: Yorkshire & Humber Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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