Breast CancerNCT06084676
Organoid Model Predictive of Response to Immunotherapies
An observational study of Breast Cancer, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Immunotherapy
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2024to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
About this study
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
- Being tested
- Immunotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 12 months
Reliability of organoid development
calculate the percentage of biopsies with successful organoid development
Measured: Baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start22 Jan 2024
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Why it stopped: difficulty recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Opyrchal, Indiana University
- Investigators
- Mateusz Opyrchal, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084676
- Sponsor's protocol ID
- CTO-IUSCCC-0804
- Status last verified
- Jul 2024
- First submitted
- 10 Oct 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organoid Model Predictive of Response to Immunotherapies
- ClinicalTrials.gov ID
- NCT06084676
- Acronym / sponsor ID
- CTO-IUSCCC-0804
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty recruiting participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapyOrganoid 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. | Drug | – |
Primary outcome
Calculate overall patient response rate
Time frame: 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
Time frame: Baseline to 2 months
calculate the percentage of biopsies with successful organoid development
Results and safety
The study was stopped early (reason given: difficulty recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mateusz Opyrchal, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty recruiting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculate overall patient response rate (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.