Evaluation of a Novel Technique for the Discovery of New, Tumor-specific Targets for the Deployment of Innovative Immunotherapeutics Against Cancer.

NCT06629233 | Enrolling By Invitation

• 2 other identifiers: ONZ-2023-0589F2022/IOF-StarTT/089
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Estrogen Receptor Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Discovery of new, tumor-specific, glycopeptide epitopes.

  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.

Study Arms (1)

Standard of care tumor resection

OTHER

Procedure: Tumor resection

Interventions

Tumor resection PROCEDURE

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.

Standard of care tumor resection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Minimally 18 years old
• Diagnosed with estrogen-receptor positive breast cancer
• This must be a primary tumor

You may not qualify if:

• Male
• Younger than 18 years old
• Previous history of other tumors

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator

Study Sites (2)

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

Location

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Interventions

Transurethral Resection of Bladder

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: September 25, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

BE (2)