Clinical trial · Observational
Prediction of Drug Response Using an Ex Vivo Organ Culture (EVOC) on Fresh Human Tumour Samples From Metastatic Patients
Prediction of Patient Drug Response Using an Ex Vivo Organ Culture (EVOC) on Fresh Human Tumour Samples From Metastatic Patients
- 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)
The primary objective of this study is to determine how sensitive and specific the Curesponse Ex Vivo Organ Culture (EVOC) model is at predicting a patient's clinical response to a specific cancer therapy. 248 patients from participating UK hospitals will have a biopsy for the development of an Ex-vivo organ culture at the Curesponse Laboratory. Patients will have standard of care anticancer therapy after the biopsy and be followed up for 6 months following their biopsy. The combined results of the study will show whether the EVOC has potential to be useful for future patients prospectively in determining whether a certain clinical treatment is likely to benefit them.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- The EVOC to demonstrate a sensitivity and specificity of at least 70% for predicting a patients clinical response to a specific anti-cancer therapy
- timeFrame
- From biopsy to the end of the patient's final imaging response assessment at Follow up 3.
- description
- Comparison of patient's treatment clinical to the EVOC treated with the same therapy.
- measure
- Assessment of tumour heterogeneity in relation to treatment response using the EVOC model
- timeFrame
- During the biopsy
- description
- Tumour gene profiling on tissue samples obtained at the biopsy
- measure
- Assess variability in cell populations within the EVOC before and after treatment.
- timeFrame
- From pre-treatment of EVOC up to the end of treatment on the EVOC model.
- description
- FACS and other methods of analysis to analyse the changes in cell population of the EVOC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Suspected or confirmed advanced or metastatic cancer 2. Aged \> 18 years 3. Life expectancy \> 3 months 4. ECOG Performance Status 0-2 5. At least one tumour lesion which is amenable for 16 G biopsy (minimum of 2 cores) 6. Planned to receive standard of care therapy or an experimental treatment as part of a clinical trial following the biopsy 7. Written informed consent and ability to comply with study protocol 8. Measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 by CT or MRI Exclusion Criteria: 1. Pregnant and/or breastfeeding woman 2. Lesion is non accessible 3. Any other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study 4. Known carrier for acquired immune deficiency syndrome (AIDS) 5. Known carrier for hepatitis B or hepatitis C virus indicating acute or chronic infection
References
Publications (0)
Data not yet available