Clinical trial · Interventional
LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer
LCC-CARIS-01: A Pilot Feasibility Study to Assess the Use of Molecular Profiling to Determine Choice of Treatment for Patients With Gynecological Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Gynaecological Malignancy | — | UNRESOLVED | — |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic Analysis
- description
- This arm will be subject to Caris Molecular profiling.
- interventionNames
- Other: Diagnostic analysis
Primary outcomes (1)
- measure
- To measure the number of treatment decisions that will be altered by the results of of the Caris molecular profiling report.
- timeFrame
- 21 days
Secondary outcomes (6)
- measure
- To analyse best response marker following CMI directed therapy
- timeFrame
- 3 years
- measure
- Determine time to treatment failure (TTTF) (defined as the time from completion of prior therapy to start of next treatment) following CMI directed therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available