CancerPOPNCT06680726
Research Collaboration for a Precision Oncology Program (POP)
An observational study of Cancer, run by Andreas Wicki at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Matching with RWD and Imaging Mass Cytometry
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Dec 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with the diagnosis of blood cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zürich (Universitätsspital Zürich)
Zurich, 8091
About this study
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.
Read the 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:
- 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).
- 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.
- Conditions
- Cancer
- Being tested
- Matching with RWD, Imaging Mass Cytometry
- Keywords
- cancer, real world data (RWD), clinical decision-making, precision oncology, advanced diagnostics, tumor tissue imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching with RWDOther
A set of clinical and genetic data are matched to generate a RWD cohort for comparison.
Imaging Mass CytometryOther
Protein expression patterns in tumor tissue and tumor microenvironment are analyzed by Imaging Mass Cytometry.
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of RWD matching report as assessed by the questionnaire
- 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?
Measured: From date of enrollment, assessed up to 2 years
Utility of the IMC report as assessed by the questionnaire
- 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?
Measured: From date of enrollment, assessed up to 2 years
Secondary outcomes (2)
Number of POP reports provided
Number (proportion) of patients in which the POP reports could be provided to the MTB
Measured: through study completion, an average of 1 year
Classification of Treatment Options
Type of treatment recommendations made by the MTB
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start11 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andreas Wicki
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, University of Zurich, University Hospital, Zürich
- Responsible party
- Sponsor-investigator, Andreas Wicki, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680726
- Sponsor's protocol ID
- POP
- Other IDs
- 2022-02289
- Acronym
- POP
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40139698
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Collaboration for a Precision Oncology Program (POP)
- ClinicalTrials.gov ID
- NCT06680726
- Acronym / sponsor ID
- POP / POP
- Conditions
- Cancer
- Keywords
- cancer, real world data (RWD), clinical decision-making, precision oncology, advanced diagnostics, tumor tissue imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Andreas WickiUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, University of Zurich, University Hospital, Zürich
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with the diagnosis of blood cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matching with RWDA set of clinical and genetic data are matched to generate a RWD cohort for comparison. | Other | – |
| Imaging Mass CytometryProtein expression patterns in tumor tissue and tumor microenvironment are analyzed by Imaging Mass Cytometry. | Other | – |
Primary outcome
Utility of RWD matching report as assessed by the questionnaire
Time frame: From date of enrollment, assessed up to 2 years
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?
Utility of the IMC report as assessed by the questionnaire
Time frame: From date of enrollment, assessed up to 2 years
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?
2 secondary outcomes
Number of POP reports provided
Time frame: through study completion, an average of 1 year
Classification of Treatment Options
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 40139698Boos 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.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Andreas Wicki at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Wicki, Professor (+41 44 255 38 99, andreas.wicki@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of RWD matching report as assessed by the questionnaire (time frame: From date of enrollment, assessed up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06680726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.