Research Collaboration for a Precision Oncology Program (POP)

NCT06680726 | Recruiting

• 2 other identifiers: POP2022-02289
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The Precision Oncology Program (POP) research collaboration aims to help generate information about the individual tumour biology for patients with advanced malignancies, using innovative biotechnologies and patient profile comparison ("matching") against specific databases (Real-world data, RWD) and to inform about potential benefit, or lack of benefit, from a given treatment.

Conditions

Cancer

Keywords

cancer; real world data (RWD); clinical decision-making; precision oncology; advanced diagnostics; tumor tissue imaging

Outcome Measures

Primary Outcomes (2)

• Utility of RWD matching report as assessed by the questionnaire

  1. Is the Report used to identify imminent or future treatment options? 2. How has the Report changed your confidence in the primary decision? 3. Does the Report support the primary therapy decision? 4. Is the relevant information in the Report non supportive of the Resources used or the primary therapy decision? 5. What Resources did you use for the primary therapy decision? 6. How useful was the Report to decide on the secondary therapy decision? 7. Which features of the Report were used for the secondary therapy decision? 8. Could you have gathered the information in the Report used for the secondary treatment decision in less than 15 min? 9. 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

  1. Is the Report used to identify imminent or future treatment options? 2. How has the Report changed your confidence in the primary decision? 3. Does the Report support the primary therapy decision? 4. Is the relevant information in the Report non supportive of the Resources used or the primary therapy decision? 5. What Resources did you use for the primary therapy decision? 6. How useful was the Report to decide on the secondary therapy decision? 7. Which features of the Report were used for the secondary therapy decision? 8. Could you have gathered the information in the Report used for the secondary treatment decision in less than 15 min? 9. Did the Report provide unique information on personalizing future treatment regimens?

  From date of enrollment, assessed up to 2 years

Secondary Outcomes (2)

• Number of POP reports provided

  through study completion, an average of 1 year

• Classification of Treatment Options

  through study completion, an average of 1 year

Interventions

Matching with RWD OTHER

A set of clinical and genetic data are matched to generate a RWD cohort for comparison.

Imaging Mass Cytometry OTHER

Protein expression patterns in tumor tissue and tumor microenvironment are analyzed by Imaging Mass Cytometry.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with the diagnosis of blood cancer.

Sponsors & Collaborators

• Andreas Wicki: lead
• Hoffmann-La Roche: collaborator
• University of Zurich: collaborator
• University Hospital, Zürich: collaborator

Study Sites (1)

University Hospital Zürich (Universitätsspital Zürich)

Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 40139698 DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Andreas Wicki, Professor

CONTACT

+41 44 255 38 99; andreas.wicki@usz.ch

Laura Boos, Dr.

CONTACT

+41 43 253 22 20; laura.boos@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 8, 2024
• Study Start: December 11, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)