Organoid Model Predictive of Response to Immunotherapies

• Sponsor: Indiana University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06084676
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Immunotherapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Organoid Model Predictive of Response to Immunotherapies
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Outcome Measures

Primary Outcome Measures

1. 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: 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

2. Reliability of organoid development [Baseline to 2 months]

   calculate the percentage of biopsies with successful organoid development

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mateusz Opyrchal, Associate Professor of Medicine, Vera Bradley Foundation Scholar in Breast Cancer, Program Leader - Phase 1, Indiana University
• ClinicalTrials.gov Identifier: NCT06084676
• Other Study ID Numbers: CTO-IUSCCC-0804
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Immunomodulating Agents

Study Results

No Results Posted as of Oct 16, 2023