Organoid Model Predictive of Response to Immunotherapies

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT06084676
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Study Start: 2024-01-22
• Primary Completion: 2024-02-26
• Study Completion: 2024-02-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calculate overall patient response rate	Baseline to 12 months	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
Reliability of organoid development	Baseline to 2 months	calculate the percentage of biopsies with successful organoid development

Trial Locations

Locations (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States