Clinical trial · Interventional
BIG Molecular Screening Feasibility Study
The BIG Molecular Screening Feasibility Study:Testing the IT Infrastructure and Logistics of a Molecular Screening Program
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot study examines the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. These assays will be performed using different laboratories and technologies from core biopsies taken from patients diagnosed with invasive recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated for ease of use to screen patients for participation in future molecularly defined clinical trials in breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- all-commers
- description
- All patients will undergo a biopsy of their metastatic lesion and have a blood sample taken for molecular screening purposes. No drugs are administered or other interventions are performed.
- interventionNames
- Procedure: biopsy
Primary outcomes (1)
- measure
- molecular screening program feasibility
- timeFrame
- 6 months after end of recruitment
- description
- To evaluate the feasibility of implementing a molecular screening program in order to identify molecular traits in patients that may render them eligible for clinical trials using specific targeted agents.
Secondary outcomes (6)
- measure
- concordance of targeted gene mutation testing by different technologies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study. 2. Age ≥ 18 years. 3. Histologically proven metastatic or locally recurrent invasive breast cancer. 4. Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes. Exclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status \>2. 2. The biopsy procedure is estimated to be too risky for the patient. 3. Any bevacizumab treatment administered less than 3 weeks before new biopsy procedure. 4. No appropriate wash-out period for patients on anticoagulation therapy.
References
Publications (0)
Data not yet available