NCT02668913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

January 21, 2016

Last Update Submit

May 7, 2024

Conditions

Epithelial Ovarian CancerPeritoneal CancerFallopian Tube CancerGynaecological Malignancy

Keywords

gynaecologyOncology

Outcome Measures

Primary Outcomes (1)

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

    21 days

Secondary Outcomes (6)

  • To analyse best response marker following CMI directed therapy

    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.

    3 years

  • Study overall survival following CMI directed therapy.

    3 years

  • Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment.

    3 years

  • Assess cost of treatment with CMI versus originally planned treatment.

    3 years

  • +1 more secondary outcomes

Study Arms (1)

Diagnostic Analysis

EXPERIMENTAL

This arm will be subject to Caris Molecular profiling.

Other: Diagnostic analysis

Interventions

Diagnostic analysisOTHER

Molecular profiling

Diagnostic Analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Geoff Hall, PhD FRCP

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lead Clinical Investigator

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 29, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2020

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

GB(1)