Research Collaboration for a Precision Oncology Program (POP)
NCT ID: NCT06680726
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-12-11
2025-12-31
Brief Summary
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Detailed Description
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The POP report will summarize the clinically-relevant findings from the following tests and procedures:
A. Routine genetic testing:
FMI (routine genetic testing) Comprehensive tumour genotyping which includes alterations in cancer-relevant genes and the following parameters: Tumor mutational burden (TMB), Loss of heterozygosity (LoH), Microsatellite Instability (MSI).
B. POP-specific additional testing:
1. Research grade: Imaging Mass Cytometry (IMC) To better capture tumour heterogeneity beyond genetics, and to inform therapy decisions of whether or not a particular treatment may show efficacy, we will perform IMC on existing formalin-fixed paraffin-embedded (FFPE) tissue sections. IMC technology enables quantification of over 40 selected proteins and protein modifications, while simultaneously interrogating phenotype and cell signaling. It allows identification of markers predictive of response (or resistance) of individual cancer patients, and enables the analysis of tumour tissues at single-cell resolution, capturing characteristics of the tumour cells, the tumour microenvironments and the relationship between tumour, stromal and immune compartments. The analysis of the tumour at the protein level and the spatial distribution of the different compartments will significantly increase and broaden the routine genetic analysis to identify potentially druggable alterations.
2. Patient Matching Against Cancer Databases The patient matching will be performed by Roche using the Flatiron Health-Foundation Medicine Clinico-genomic Database (FH-FMI CGDB).
The following scenarios will be explored as part of the project:
(i) a comparison of clinical data (e.g. entity, TNM classification, previous therapies, etc) to extract similar clinical phenotypes and the related treatment history and outcomes (clinical level) (ii) a comparison at the genotype level (genomic level) (iii) a combination of the possibilities above.
The POP report will be shared with the Molecular Tumour Board (MTB) and discussed in the absence of the treating physician. The MTB will consider all available information at its own discretion and in adherence to the available standard guidelines. However, only treatment recommendations based on routine diagnostics will be forwarded to the treating physician. Hypothetical MTB's treatment decisions based on the POP summary report will not be forwarded the treating physician.
NOTE: All additional project specific recommendations remain non-prescriptive and will not be forwarded to the treating physician.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Matching with RWD
A set of clinical and genetic data are matched to generate a RWD cohort for comparison.
Imaging Mass Cytometry
Protein expression patterns in tumor tissue and tumor microenvironment are analyzed by Imaging Mass Cytometry.
Eligibility Criteria
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Inclusion Criteria
* In the case of deceased persons: signed general consent
* All patients with the diagnosis of a solid tumour including adenocarcinoma, squamous cell carcinoma, neuroendocrine carcinoma, sarcoma, etc
* ECOG-performance status 0-2, if applicable
* Willing and able to understand all project related procedures, including transfer of coded (i.e. pseudonymised) or anonymized clinical data to external partners (e.g. Roche), if applicable
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
University of Zurich
OTHER
University Hospital, Zürich
OTHER
Andreas Wicki
OTHER
Responsible Party
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Andreas Wicki
Professor
Locations
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University Hospital Zürich (Universitätsspital Zürich)
Zurich, , Switzerland
Countries
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Central Contacts
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References
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Boos LA, Doerig C, Gut G, Miglino N, Fabregas Ibanez L, Rizzo S, Scharfe Fruechtenicht C, Chitale N, Lu C, Zoche M, Bodenmiller B, Chevrier S, Eklund AS, Nowak M, Rahmani Khajouei S, Berardo CG, Kaczmarek L, Bosshard K, Archey W, Bodmer M, Glinz D, Camarillo-Retamosa E, Hempel CL, Rahimzadeh P, Gosztonyi B, Richter U, Bankel L, Wicki A. Precision Oncology Program (POP), an observational study using real-world data and imaging mass cytometry to explore decision support for the Molecular Tumor Board: study protocol. BMJ Open. 2025 Mar 26;15(3):e096591. doi: 10.1136/bmjopen-2024-096591.
Other Identifiers
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2022-02289
Identifier Type: OTHER
Identifier Source: secondary_id
POP
Identifier Type: -
Identifier Source: org_study_id
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