Matching with RWD and Imaging Mass Cytometry in Cancer - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Cancer

Intervention / Treatment

Detailed Description

This is an observational clinical project. The aim of this research collaboration is to establish processes to advance precision oncology within the clinical routine. POP generates information about individual tumour for patients with advanced cancers using innovative molecular technologies and patient profile comparison ("matching") against specific public and non-public databases with the aim to support clinical decision-making (therapy prediction).

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:

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.
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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Andreas Wicki, Professor
Phone Number: +41 44 255 38 99
Email: andreas.wicki@usz.ch

Study Contact Backup

Name: Laura Boos, Dr.
Phone Number: +41 43 253 22 20
Email: laura.boos@usz.ch

Study Locations

Switzerland
- - Zürich, Switzerland, 8091
    - Recruiting
    - University Hospital Zürich (Universitätsspital Zürich)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with histology based proven diagnosis of cancer; all stages and subtypes can be included. Pre-cancerous lesions, e.g. DCIS, LCIS, CIN, etc. cannot be included.

Description

Inclusion Criteria:

Signed informed consent
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:

Patients with the diagnosis of blood cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of RWD matching report as assessed by the questionnaire Time Frame: From date of enrollment, assessed up to 2 years	Is the Report used to identify imminent or future treatment options? How has the Report changed your confidence in the primary decision? Does the Report support the primary therapy decision? Is the relevant information in the Report non supportive of the Resources used or the primary therapy decision? What Resources did you use for the primary therapy decision? How useful was the Report to decide on the secondary therapy decision? Which features of the Report were used for the secondary therapy decision? Could you have gathered the information in the Report used for the secondary treatment decision in less than 15 min? Did the Report provide unique information on personalizing future treatment regimens?	From date of enrollment, assessed up to 2 years
Utility of the IMC report as assessed by the questionnaire Time Frame: From date of enrollment, assessed up to 2 years	Is the Report used to identify imminent or future treatment options? How has the Report changed your confidence in the primary decision? Does the Report support the primary therapy decision? Is the relevant information in the Report non supportive of the Resources used or the primary therapy decision? What Resources did you use for the primary therapy decision? How useful was the Report to decide on the secondary therapy decision? Which features of the Report were used for the secondary therapy decision? Could you have gathered the information in the Report used for the secondary treatment decision in less than 15 min? Did the Report provide unique information on personalizing future treatment regimens?	From date of enrollment, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of POP reports provided Time Frame: through study completion, an average of 1 year	Number (proportion) of patients in which the POP reports could be provided to the MTB	through study completion, an average of 1 year
Classification of Treatment Options Time Frame: through study completion, an average of 1 year	Type of treatment recommendations made by the MTB	through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andreas Wicki

Collaborators

University of Zurich

Hoffmann-La Roche

University Hospital, Zürich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)