A Non-interventional, International, Multicentre Clinical Research Study to Build the Largest Collection of Multimodal Data (Including Clinical Data, Imaging Data and Omics Data) in Oncology (MOSAIC)

October 1, 2024 updated by: OWKIN

Multi Omics and Spatial Atlas In Cancer

Cancer is amongst the leading causes of disease-related morbidity and mortality. A major challenge in cancer treatment is the development of biology-informed, personalised treatment strategies. Recent advances in artificial intelligence (AI) and next-generation sequencing (NGS) technologies have shed further insights into disease biology and treatment pathways, thus identifying new, precision medicine-based therapeutic opportunities.

The biological mechanisms leading to cancer development and progression arise from complex and plastic networks of dysregulated cellular programs involving many signalling pathways and effector molecules. Cancer cells alter their surrounding environment via cell-cell interactions with non-tumor cells or by secreting cytokines, chemokines and other factors. This reprogramming of the tumour microenvironment (TME) is critical for cancer progression, invasion, and metastasis. Moreover, there are increasing studies that show that both innate and adaptive immune cell types contribute to tumorigenesis and treatment resistance when present within the TME. Understanding the crosstalk between cancer cells and the surrounding TME will inform on mechanisms of sensitivity and resistance to treatment, including immunotherapy (IO) and targeted therapies.

Spatially resolved-Omics is an emerging field that characterises cell types by gene/protein expressions within their spatial context in the tissue organisation. Recent high profile spatial transcriptomics studies have uncovered specific cell identities that define the surrounding TME.

The MOSAIC study, a collaborative initiative across industry and top oncology hospitals, proposes to go way beyond current cancer molecular profiling projects by combining the generation and analysis of multiple data modalities (3 essential mandatory modalities: Clinical Data, Hematoxylin and Eosin (H&E) microscopic image, Spatial transcriptomics; up to 3 high priority data modalities depending on technical feasibility and sample size: bulk Ribonucleic Acid Sequencing (RNAseq), bulk Whole Exome Sequencing (WES), Single-cell transcriptomics; and potentially other optional data modalities and follow-up experiments such as single-cell omics, immunohistochemistry and spatial proteomics or other molecular profiling of proteins and molecules) on a minimum of 2,000 tumour samples across a different cancer indications. This will generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients, integrated with clinical data, at an unprecedented scale and resolution.

This study will enroll patients diagnosed with one of the eligible cancer indications and for which a formalin fixed paraffin embedded (FFPE) tumor sample from already performed biopsy and/or surgical resection is available within their local pathology archive or their affiliate centers archives.

The MOSAIC study expects to have a strong impact for patients in terms of new targeted therapeutic drug discovery, identification of patient subgroups requiring either specific treatment or broader clinical care and identification of novel treatment response and resistance mechanisms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7000

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Prof.Dr. Ulrich Keilholz
      • Erlangen, Germany
        • Recruiting
        • Universiy Hospital Erlangen & FAU Erlangen-Nürnberg
        • Contact:
        • Contact:
        • Principal Investigator:
          • PD Dr. med. Ramona Erber
        • Principal Investigator:
          • PD Dr. med. Markus Eckstein
  • Switzerland
      • Lausanne, Switzerland
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Raphael Gottardo
        • Sub-Investigator:
          • Dr. Krisztian Homicsko
  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15238
        • Recruiting
        • University of Pittsburgh
        • Contact:
        • Contact:
        • Principal Investigator:
          • Devin Dressman, Ph.D.
        • Principal Investigator:
          • Dr. Adrian Lee

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients across different cancer indications, which include, but are not restricted to histologically confirmed solid tumors (all types and subtypes) and diffuse large B cell lymphoma (DLBCL) and for which there is a formalin fixed and paraffin embedded (FFPE) tumor sample from already performed biopsy and/or surgical resection available.

Description

Inclusion Criteria:

  1. That the patient was over the age of 18 when the sample was taken/consented to.
  2. Availability of patient informed consent or non-opposition form to perform exploratory research matching at least one of the MOSAIC objectives (unless authorisation is granted by the local Institutional Review Board / Independent Ethics Committee (IRB/IEC) for the use of samples in the study according to local regulations and law).
  3. Have a confirmed diagnosis based on international criteria for the relevant tumor type.
  4. Confirmed formalin fixed and paraffin embedded (FFPE) tissue availability to generate at least the 3 core data modalities, and preferentially all MOSAIC data modalities.
  5. Confirmed availability of associated clinical data.

  6. Qualification of the paraffin tissue block meeting all of the following:

    • Being of the expected tumor type
    • For solid tumors (all cancer indications except diffuse large B cell lymphoma (DLBCL)): Tumor cell content ranging from 40% to 80% on an hematoxylin and eosin (H&E) section within a specified area as dictated by the lab protocol specific to the technique utilized
    • For DLBCL, a minimum of 80% of high grade component on an H&E section within a specified area as dictated by the lab protocol specific to the technique utilized
    • Wherever possible, the remaining tissue thickness must be over 125 micrometers (indicative range)
    • Tumor sample must be <10 years old

In addition, each sub-cohort within each cancer indication will have specific inclusion criteria (e.g., disease stage; sampling site; treatment received…).

Exclusion Criteria:

1. Samples without a preserved tissue architecture, such as cytologies and cytoblocks.

In addition, each sub-cohort within each cancer indication may have specific exclusion criteria (e.g. histological subtype; history of immunosuppression; etc…).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients diagnosed with one of the eligible cancers and having at least one archived FFPE sample

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary endpoint will be genes or proteins that present features compatible with drug targeting and/or novel biomarkers, and that are specific to a given patient population within one or more cancer indications.
Time Frame: From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years

Unsupervised data analysis and outcome measures will be used to achieve this, such as prognosis under treatment, response to specific therapies. The response to therapy will be assessed based on the data related to the treatment and its efficacy collected via an electronic Case Report Form. For each patient at baseline and throughout the MOSAIC follow up period, the following data will help to assess this: all the different cancer treatments (surgery,…) and their outcomes ; the concurrent treatment (drug name, …); the state of the cancer, i.e complete or partial response, or progression, measured at various time-points specific to each tumor type.

Because the study will utilize tumor samples collected largely <10 years ago, survival information may not be present for all patients by the end of the study, especially in slow evolving tumor types. For this reason, we will use tumor type-specific prognostic markers and scores as surrogates of prognosis whenever available and necessary.
From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Biological mechanisms and/or pathways associated to patient outcomes under treatment, independently from therapeutic potential
Time Frame: From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years
From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years
Novel classification of patients subgroups within each cancer indications, based on one or more data modalities, representing homogeneous biology
Time Frame: From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years
From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years
Novel biomarkers that may be: a single gene/protein or a signature; a histological or spatial feature; a combined biomarker, ideally transferable to routine clinical use, and which predicts prognosis or other clinically actionable information.
Time Frame: From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years
From date of cancer diagnosis until date of death, date of lost of follow-up, date of consent withdrawal, or date of end of study (Dec 2028), whichever occurs first, assessed up to 16 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OWKIN

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dr. Vassili Soumelis, OWKIN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23.00242.000244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pseudonymized, preprocessed, and minimized data belonging to a subset of deceased patients is going to be made available to researchers on the European Genome-Phenome Archive (EGA). This project is called MOSAIC-Window.

In addition, following the ten years of the MOSAIC research study, the collected and generated data within MOSAIC will be anonymized in compliance with applicable laws and regulation, and a public version of the MOSAIC data will be released for research purposes. A dedicated committee of the study will decide on the conditions and modalities of the anonymization.

IPD Sharing Time Frame

MOSAIC-Window start date: Q3 2024

IPD Sharing Access Criteria

Prior to uploading the data to the EGA, Owkin ensures that all personal data embedded in the datasets are pseudonymized and encrypted both in transit and at rest. Owkin is responsible for obtaining and demonstrating the existence of data subjects' informed consent or any other suitable legal basis for processing personal data, obtaining appropriate ethical or other approvals for collecting the data, and complying with applicable Data Protection Laws.

Researchers from institutions outside the MOSAIC Consortium will be able to ask for access to this data, specifying the research questions they want to answer. A Data Access Committee (DAC) will evaluate the researcher's application and decide whether to give access to the MOSAIC-Window dataset or not. If the application is successful, the researcher will agree with the terms and conditions defined by the DAC (e.g. creative common license, no re-identification of patients, etc.) and then will be able to download the data for analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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