RecruitingNCT05652569

CATCH: Implementation of Genomics-guided Precision Medicine in Metastatic Breast Cancer

Comprehensive Assessment of Clinical Features and Biomarkers to Identify Patients With Advanced or Metastatic Breast Cancer for Marker Driven Trials in Humans (CATCH)


Sponsor

German Cancer Research Center

Enrollment

5,000 participants

Start Date

Jun 12, 2017

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 14 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

Interventions

OTHERGenomic Profiling / Sequencing

Procedure: genomic profiling (Whole-Genome- / Exome-Sequencing + RNA-Sequencing) on metastatic biopsy lesions


Locations(12)

University Hospital Augsburg

Augsburg, Germany

Charité

Berlin, Germany

University Hospital Köln

Cologne, Germany

Medical Faculty and University Hospital Carl Gustav Carus

Dresden, Germany

University Hospital Erlangen

Erlangen, Germany

University Hospital Essen

Essen, Germany

National Center for Tumor Diseases

Heidelberg, Germany

Caritas Hospital St. Josef

Regensburg, Germany

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart, Germany

University Hospital Tübingen

Tübingen, Germany

University Hospital Ulm

Ulm, Germany

University Hospital Würzburg

Würzburg, Germany

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