Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05652569 |
| Other study ID # |
S-164/2017 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 12, 2017 |
| Est. completion date |
December 31, 2030 |
Study information
| Verified date |
May 2024 |
| Source |
German Cancer Research Center |
| Contact |
Andreas Schneeweiss, MD |
| Phone |
0049-6221-5636051 |
| Email |
Andreas.Schneeweiss[@]med.uni-heidelberg.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
Description:
Study Flow
CATCH has the goal to implement personalized oncology workflows into the clinic. The clinical
precision oncology core backbone encompasses a streamlined diagnostic end-to-end pipeline:
Patient screening and enrolment: Metastatic breast cancer (mBC) patients at initial diagnosis
of locally-advanced-/ distant metastasis and any other clinical progress are screened for
eligibility. The treating physician has to obtain written informed consent prior to
enrolment.
Collection of biomaterial: Fresh-frozen tumor tissue from progressive prognostic-relevant
metastatic lesions is collected during standard-of-care routine procedures at study entry.
Consecutive biopsies can be offered at progress. Blood samples are taken at baseline (V1) to
account for germline controls and can be sequentially repeated at 3-monthly intervals for
monitoring of therapy response.
Processing and analyses of patient samples: Biomaterials are centrally processed (standard
histology/IHC and pathology review for tumor content; analyte extraction, QC according to
standardized, quality-controlled, accredited workflows (DIN EN ISO/IEC 17025). Analyte
extraction on fresh-frozen tissue encompasses DNA, RNA and protein isolation.
Molecular profiling (Sequencing): Genomic profiling (DIN EN ISO/IEC 17025) is centrally
processed to ensure standardization and encompasses whole-genome sequencing (WGS) on
fresh-frozen tissue biopsies or whole-exome sequencing (WES) on FFPE specimens (in case of
unsuccessful biopsy sampling on recent lesion due to low tumor cell content) complemented by
RNA-sequencing.
Clinical bioinformatics /Data curation: Tumor- and treatment-relevant genomic aberrations
together with standard clinical as well as histopathological parameters are analyzed and put
into the clinical context to delineate biomarkers and actionable alterations as well as to
tackle the underlying biology of treatment-resistance.
Molecular Tumor Board (MTB): Molecular data and conclusive biomarker profiles are discussed
by clinicians, bioinformaticians, molecular biologists, human geneticists and pathologists in
a weekly interdisciplinary MTB established at NCT Heidelberg. Treatment-relevant biomarkers
and actionable drug targets are validated independently. Therapeutic options are prioritized
within a molecular report.
Therapy Implementation: Patients will be informed in detail by the treating physician to
discuss potential genetically-tailored treatment options. The major goal is to offer patients
further interventional clinical trials and drive assignment towards genomics-guided matched
biomarker / drug combinations.
Follow-up / Documentation Schedule: Clinical documentation is conducted by authorized study
personal at study entry in a certified electronic case report form (eCRF) and subsequently
every 3 months for at least 3 years, at any staging interval or cancer-specific therapy
change to generate a comprehensive patient registry. To ascertain comprehensive follow-up,
only patients will be enrolled who will be treated locally at the involved trial sites.
Molecular data will be systematically collected to drive translational exploratory research
projects.
The following data are collected and stored (baseline and follow-up assessments)
- patient identifier /demographics (including sex, age at diagnosis, family history)
- cancer type / medical history / characteristics diagnosis (including date of diagnosis)
- clinical outcome / longitudinal disease assessments: relapse and progression
- genomic and transcriptomic data
- ECOG status
- sample information (e.g. specimen type, tumor histological type, anatomical location,
tissue analyses)
- health-related Quality-of-Life (QoL) / Patient-Reported Outcomes (PROs)
Translational scientific companion programs: Excess biomaterial not needed for the diagnostic
precision oncology approach can be used for exploratory research (e.g. ex vivo approaches,
liquid biopsies, immunophenotyping).
Results / Outcome Evaluation:Molecular data will be analysed and interpreted on complementary
levels. Biomarkers and molecular aberrations such as mutations, amplifications and aberrant
gene expression are evaluated for their tumor-relevance and clinical potential to assign
patients for specific clinical trials with targeted treatment approaches.
