NCT05652569 CATCH: Implementation of Genomics-guided Precision Medicine in Metastatic Breast Cancer
| NCT ID | NCT05652569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | German Cancer Research Center |
| Condition | Metastatic Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2017-06-12 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2017-06-12 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CATCH is an indication-specific diagnostic platform, which drives the implementation of integrative, genomic profiling for metastatic breast cancer into the clinics. The main objective of this approach is to identify biomarkers and drug targets to guide targeted therapeutic interventions. Eligible are all metastatic breast cancer patients (independent of gender), irrespective of molecular subtype. At initial diagnosis of distant metastasis or progress at disease progression, biopsy samples from a prognostic-relevant metastasis are retrieved during standard-of-care procedures for central analyses, together with blood samples. In parallel to all standard-diagnostic measures, genomic and transcriptomic profiling is conducted to infer the underlying biology of the disease and identify patients who might profit from biomarker-guided interventions in clinical trials. Samples not required for standard-of-care clinical procedures or genomic profiling are systematically collected in a dedicated bio-repository to fuel translational scientific companion programs. The continuously growing comprehensive database serves as an integrative resource for systematic, prospective multidimensional data collection (clinical records, biomaterial, genomic data). In summary, the overarching goal is to generate a precision oncology platform to i) identify clinically-actionable biomarkers and drug targets that drive genomics-guided therapies and ii) couple the observational, diagnostic registry platform to an increasing number of independent, biomarker-stratified clinical therapy trials (CATCH-GUIDE).
Eligibility Criteria
Inclusion Criteria: * Female and male breast cancer patients ≥ 18 or if the legal guardian has agreed to the respective informed consent form (ICF) * Patients with advanced or metastatic breast cancer (irrespective of clinical parameters such as TNM, subgroups, therapy lines) * Patients, who agreed to and were able to sign the informed consent form. Exclusion Criteria: * Early breast cancer * Inability to take a tissue bioptic sample due to reasons such as physical location of the lesion or health of the patient * Any physical or mental handicap or severe comorbidities that would hamper the adequate cooperation with the patient.
Contact & Investigator
Andreas Schneeweiss, MD
PRINCIPAL INVESTIGATOR
National Center for Tumor Diseases, Heidelberg
Frequently Asked Questions
Who can join the NCT05652569 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 100 Years, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05652569 currently recruiting?
Yes, NCT05652569 is actively recruiting participants. Contact the research team at Andreas.Schneeweiss@med.uni-heidelberg.de for enrollment information.
Where is the NCT05652569 trial being conducted?
This trial is being conducted at Augsburg, Germany, Berlin, Germany, Cologne, Germany, Dresden, Germany and 8 additional locations.
Who is sponsoring the NCT05652569 clinical trial?
NCT05652569 is sponsored by German Cancer Research Center. The principal investigator is Andreas Schneeweiss, MD at National Center for Tumor Diseases, Heidelberg. The trial plans to enroll 5,000 participants.
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