- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06629233
Evaluation of a Novel Technique for the Discovery of New, Tumor-specific Targets for the Deployment of Innovative Immunotherapeutics Against Cancer. (Tn-Miner)
Tn-Miner: Technology for the Discovery of Tumor-specific Glycopeptide Immunotherapy Targets.
The goal of this interventional, prospective research on human bodily material is to discover new, cancer-specific molecular structures (i.e. glycopeptides) within surgically removed, estrogen receptor positive breast cancer tumors.
The main goal it aims to achieve is:
To discover tumor-specific targets, that allow the use of very potent immunotherapeutic drugs as treatment for solid tumors, such as estrogen receptor positive breast cancer. These new targets are very specific for cancer cells, meaning that virtually no healthy cells should be attacked by the treatment, resulting in less side effects.
Participants will undergo standard of care treatment, comprising surgical removal of the breast tumor. Part of these tissues will be used for this clinical research.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
East-Flanders
-
Ghent, East-Flanders, Belgium, 9000
- University Hospital Ghent
-
Ghent, East-Flanders, Belgium, 9000
- AZ Maria Middelares
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female
- Minimally 18 years old
- Diagnosed with estrogen-receptor positive breast cancer
- This must be a primary tumor
Exclusion Criteria:
- Male
- Younger than 18 years old
- Previous history of other tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Standard of care tumor resection
|
As the standard of care, estrogen receptor-positive breast tumors are surgically resected.
From these resected tumors, small samples of both cancer tissue and healthy surrounding tissue will be analyzed using our patented Tn-Miner workflow to discover novel tumor-specific epitopes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discovery of new, tumor-specific, glycopeptide epitopes.
Time Frame: The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.
|
The discovery of new antigens, comprising both glycan and peptide (=glycopeptide), on the outside of the plasma membrane of the breast cancer cells.
These antigens should be absent on healthy cells.
These new, glycopeptide antigens can be used as target for immunotherapeutics against cancer.
|
The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2023-0589
- F2022/IOF-StarTT/089 (Other Grant/Funding Number: Industrial Research Fund (IOF, UGent))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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