Organoid Model Predictive of Response to Immunotherapies

NCT06084676 | Terminated DMC

• 1 other identifier: CTO-IUSCCC-0804
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Calculate overall patient response rate

  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

  Baseline to 12 months

• Reliability of organoid development

  calculate the percentage of biopsies with successful organoid development

  Baseline to 2 months

Interventions

Immunotherapy DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are planning on receiving a fresh biopsy sample will be identified in the IU Oncology outpatient clinics or by referral from outside physicians.

You may qualify if:

• ≥ 18 years old at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization
• Biopsy proven diagnosis of cancer
• Able to obtain at least 2 16 gage cores of fresh tissue safely (3 or more cores preferred)
• Planning to undergo standard of care Immunotherapy
• Baseline standard of care CT within 8 weeks of starting Immunotherapy

You may not qualify if:

• Inability to provide fresh biopsy sample
• Any active infections
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Mateusz Opyrchal, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Vera Bradley Foundation Scholar in Breast Cancer, Program Leader - Phase 1

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: January 22, 2024
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

US (1)