Epithelial Ovarian CancerNCT02668913
LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer
A study testing Diagnostic analysis in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Geoff Hall at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Diagnostic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
About this study
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
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.
Read the 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
- Being tested
- Diagnostic analysis
- Keywords
- gynaecology, Oncology
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic analysisOther
Molecular profiling
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Analysis | Experimental | This arm will be subject to Caris Molecular profiling. Receives: Other: Diagnostic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the number of treatment decisions that will be altered by the results of of the Caris molecular profiling report.
Measured: 21 days
Secondary outcomes (6)
To analyse best response marker following CMI directed therapy
Measured: 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.
Measured: 3 years
Study overall survival following CMI directed therapy.
Measured: 3 years
Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment.
Measured: 3 years
Assess cost of treatment with CMI versus originally planned treatment.
Measured: 3 years
To analyse quality adjusted life years (QALYs) in patients treated with CMI-directed therapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2018
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geoff Hall
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor-investigator, Geoff Hall, University of Leeds
- Investigators
- Geoff Hall, PhD FRCP, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668913
- Sponsor's protocol ID
- MO15/302
- Other IDs
- 15/YH/0493
- Status last verified
- May 2024
- First submitted
- 21 Jan 2016
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02668913
- Acronym / sponsor ID
- MO15/302
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Gynaecological Malignancy
- Keywords
- gynaecology, Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Geoff HallUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Analysis | Experimental | Other: Diagnostic analysisThis arm will be subject to Caris Molecular profiling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic analysisMolecular profiling | Other | Diagnostic Analysis |
Primary outcome
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
6 secondary outcomes
To analyse best response marker following CMI directed therapy
Time frame: 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
Study overall survival following CMI directed therapy.
Time frame: 3 years
Compare the ratio of TTTF after CMI guided therapy to TTTF under previous treatment.
Time frame: 3 years
Assess cost of treatment with CMI versus originally planned treatment.
Time frame: 3 years
To analyse quality adjusted life years (QALYs) in patients treated with CMI-directed therapy.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff Hall, PhD FRCP principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic analysis in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Geoff Hall at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.