Organoid Model Predictive of Response to Immunotherapies

Breast Cancer Clinical Trial

Official title:

Organoid Model Predictive of Response to Immunotherapies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084676
• Other study ID #: CTO-IUSCCC-0804
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: Anne Younger
• Phone: 3172740951
• Email: anefoste[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Immunotherapy
Organoid samples will be collected at time of biopsy and cultured in the lab. The samples will then receive the same standard of care immunotherapy treatment as the patient.

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculate overall patient response rate	Compare patient response using RECIST 1.1 criteria and immune-organoid response based on the following criteria: Complete response <50% of viable tumor cells; Response >50%<70% of viable tumor cells; Stable >70%<90% viable tumor cell left; Progressive >90% of viable tumor cell left	Baseline to 12 months
Primary	Reliability of organoid development	calculate the percentage of biopsies with successful organoid development	Baseline to 2 months