Clinical trial · Observational
Organoid Model Predictive of Response to Immunotherapies
NCT06084676CI-TRIAL-00078896terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulty recruiting participants
Summary
Brief summary (as posted)
The purpose of this study is to create models out of tissue samples and treat those models with the same immunotherapy treatment the patient will be receiving, in order to validate this process and to predict responses to therapies and use it to choose the best treatments for people in the future. The researchers will then examine the direct effects of the treatment on those models.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Calculate overall patient response rate
- timeFrame
- Baseline to 12 months
- description
- Compare patient response using RECIST 1.1 criteria and immune-organoid response based on the following criteria: 1. Complete response \<50% of viable tumor cells 2. Response \>50%\<70% of viable tumor cells 3. Stable \>70%\<90% viable tumor cell left 4. Progressive \>90% of viable tumor cell left
- measure
- Reliability of organoid development
- timeFrame
- Baseline to 2 months
- description
- calculate the percentage of biopsies with successful organoid development
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Biopsy proven diagnosis of cancer 4. Able to obtain at least 2 16 gage cores of fresh tissue safely (3 or more cores preferred) 5. Planning to undergo standard of care Immunotherapy 6. Baseline standard of care CT within 8 weeks of starting Immunotherapy Exclusion Criteria: 1. Inability to provide fresh biopsy sample 2. Any active infections 3. Any conditions that in the opinion of treating physician and the study team will compromise the ability of the patient to receive prescribed treatment to assess the response.
References
Publications (0)
Data not yet available
No reference posted for this study.