Actively Recruiting
COGNITION: Comprehensive Assessment of Clinical Features, Genomics and Molecular Markers to Identify Early Breast Cancer Patients for Marker-Driven Trials
Led by German Cancer Research Center · Updated on 2025-03-19
2000
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
G
German Cancer Research Center
Lead Sponsor
U
University Hospital Heidelberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a genomic diagnostic platform called COGNITION to understand why some high-risk early breast cancer patients do not respond well to standard neoadjuvant chemotherapy. The study aims to create a comprehensive genomic profile of tumors before and after chemotherapy, helping to identify biomarkers for more precise, personalized treatments. This observational trial supports a linked phase II clinical trial, COGNITION-GUIDE, which uses these biomarker results to guide therapy choices. The study involves collecting fresh-frozen tumor tissue and blood samples from patients at multiple points: before any treatment, after chemotherapy, and sometimes after surgery. These samples undergo detailed genomic and molecular analyses including whole-genome or exome sequencing and RNA sequencing. A multidisciplinary team reviews the data to identify treatment-relevant biomarkers and mutations. The findings guide recommendations for personalized treatment arms in the linked clinical trial. Additional research programs use leftover samples to study therapy resistance and cancer progression. Participants will be registered and monitored with clinical data and biomaterial collection from the start and every six months for up to ten years. The study collects extensive molecular and clinical information, including tumor profiles and immune environment characteristics. Researchers will track treatment responses and resistance using liquid biopsies and analyze genetic factors affecting drug metabolism. This long-term follow-up aims to build a detailed platform for precision oncology in early breast cancer.
CONDITIONS
Brief Title
COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and male breast cancer patients aged 18 to 80 years
- Patients with primary early breast cancer or isolated loco-regional relapse treatable with curative intent
- Patients planned to receive neoadjuvant chemotherapy enrolled before starting treatment or after last chemotherapy cycle if no complete response
- Patients after surgery and during or planned post-neoadjuvant chemotherapy with specific breast cancer subtypes and non-complete response
- Willingness to donate a recent tumor tissue sample, preferably fresh
- Ability and willingness to sign the informed consent form
You will not qualify if you...
- Patients who did not sign or withdrew informed consent
- Inability to obtain tissue for molecular profiling
- Any physical or mental condition that prevents adequate cooperation with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Baseline and post-neoadjuvant chemotherapy periods
Participants provide fresh-frozen tumor tissue and blood samples during routine procedures before and after neoadjuvant chemotherapy to enable genomic profiling and molecular analysis.
2 visits (in-person) for sample collection at baseline and after neoadjuvant chemotherapy
Duration - Up to 10 years
Participants are followed up every 6 months for up to 10 years to monitor clinical outcomes and collect data for ongoing research.
Follow-up visits every 6 months
Trial Site Locations
Total: 12 locations
1
University Hospital Augsburg
Augsburg, Germany
Actively Recruiting
2
Charité - Berlin
Berlin, Germany
Actively Recruiting
3
University Hospital Köln
Cologne, Germany
Not Yet Recruiting
4
Medical Faculty and University Hospital Carl Gustav Carus
Dresden, Germany
Actively Recruiting
5
University Hospital Erlangen
Erlangen, Germany
Actively Recruiting
6
University Hospital Essen
Essen, Germany
Not Yet Recruiting
7
National Center for Tumor Diseases (NCT) Heidelberg
Heidelberg, Germany
Actively Recruiting
8
Caritas Hospital St. Josef
Regensburg, Germany
Actively Recruiting
9
Robert Bosch Hospital Stuttgart
Stuttgart, Germany
Actively Recruiting
10
University Hospital Tübingen
Tübingen, Germany
Actively Recruiting
11
University Hospital Ulm
Ulm, Germany
Actively Recruiting
12
University Hospital Würzburg
Würzburg, Germany
Actively Recruiting
Research Team
A
Andreas Schneeweiss, MD
P
Peter Lichter, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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