LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer

NCT ID: NCT02668913

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-10-31

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.

Conditions

Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer; Gynaecological Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic Analysis

This arm will be subject to Caris Molecular profiling.

Group Type: EXPERIMENTAL

Diagnostic analysis

Intervention Type: OTHER

Molecular profiling

Interventions

Diagnostic analysis

Molecular profiling

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Geoff Hall

OTHER

Sponsor Role: lead

Responsible Party

Geoff Hall

Lead Clinical Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Geoff Hall, PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

15/YH/0493

Identifier Type: OTHER

Identifier Source: secondary_id

MO15/302

Identifier Type: -

Identifier Source: org_study_id