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Diffuse Large B Cell LymphomaMOSAICNCT06625203

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

An observational study of Diffuse Large B Cell Lymphoma and Solid Tumor Cancer, run by OWKIN at 5 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
7,000 participants
Where
5 sitesin 4 countries
Study dates
8 May 2023to Dec 2028
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: 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.

Who may be able to join

  • That the patient was over the age of 18 when the sample was taken/consented to.
  • 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).
  • Have a confirmed diagnosis based on international criteria for the relevant tumor type.
  • Confirmed formalin fixed and paraffin embedded (FFPE) tissue availability to generate at least the 3 core data modalities, and preferentially all MOSAIC data modalities.
  • Confirmed availability of associated clinical data.
  • Qualification of the paraffin tissue block meeting all of the following:
Show all 12Show fewer
  • 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…).

Who cannot join

  • 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…).

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Germany2 sites
  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universiy Hospital Erlangen & FAU Erlangen-Nürnberg

    Erlangen

Other trials in Germany

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15238

Other trials in United States

France1 site
  • Gustave Roussy

    Paris

Other trials in France

Switzerland1 site
  • Centre Hospitalier Universitaire Vaudois

    Lausanne

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Keywords
Oncology, Multimodal Data, Omics Data, Database, Spatial Omics Data, Spatial Transcriptomic
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06625203
Study groupRoleWhat they receive
Patients diagnosed with one of the eligible cancers and having at least one archived FFPE sampleNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: 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 outcomes (3)
  1. Biological mechanisms and/or pathways associated to patient outcomes under treatment, independently from therapeutic potential

    Measured: 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

  2. Novel classification of patients subgroups within each cancer indications, based on one or more data modalities, representing homogeneous biology

    Measured: 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

  3. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start8 May 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Retrospective
Enrolment
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625203
Sponsor's protocol ID
23.00242.000244
Acronym
MOSAIC
Status last verified
Sep 2026
First submitted
30 Aug 2024
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Wu Y, Yang S, Ma J, Chen Z, Song G, Rao D, Cheng Y, Huang S, Liu Y, Jiang S, Liu J, Huang X, Wang X, Qiu S, Xu J, Xi R, Bai F, Zhou J, Fan J, Zhang X, Gao Q. Spatiotemporal Immune Landscape of Colorectal Cancer Liver Metastasis at Single-Cell Level. Cancer Discov. 2022 Jan;12(1):134-153. doi: 10.1158/2159-8290.CD-21-0316. Epub 2021 Aug 20.

    PubMed 34417225
  • Rao A, Barkley D, Franca GS, Yanai I. Exploring tissue architecture using spatial transcriptomics. Nature. 2021 Aug;596(7871):211-220. doi: 10.1038/s41586-021-03634-9. Epub 2021 Aug 11.

    PubMed 34381231
  • Meylan M, Petitprez F, Becht E, Bougouin A, Pupier G, Calvez A, Giglioli I, Verkarre V, Lacroix G, Verneau J, Sun CM, Laurent-Puig P, Vano YA, Elaidi R, Mejean A, Sanchez-Salas R, Barret E, Cathelineau X, Oudard S, Reynaud CA, de Reynies A, Sautes-Fridman C, Fridman WH. Tertiary lymphoid structures generate and propagate anti-tumor antibody-producing plasma cells in renal cell cancer. Immunity. 2022 Mar 8;55(3):527-541.e5. doi: 10.1016/j.immuni.2022.02.001. Epub 2022 Feb 28.

    PubMed 35231421
  • Gonzalez H, Hagerling C, Werb Z. Roles of the immune system in cancer: from tumor initiation to metastatic progression. Genes Dev. 2018 Oct 1;32(19-20):1267-1284. doi: 10.1101/gad.314617.118.

    PubMed 30275043
  • Hegde PS, Chen DS. Top 10 Challenges in Cancer Immunotherapy. Immunity. 2020 Jan 14;52(1):17-35. doi: 10.1016/j.immuni.2019.12.011.

    PubMed 31940268
  • Hanahan D, Coussens LM. Accessories to the crime: functions of cells recruited to the tumor microenvironment. Cancer Cell. 2012 Mar 20;21(3):309-22. doi: 10.1016/j.ccr.2012.02.022.

    PubMed 22439926
  • Cable DM, Murray E, Zou LS, Goeva A, Macosko EZ, Chen F, Irizarry RA. Robust decomposition of cell type mixtures in spatial transcriptomics. Nat Biotechnol. 2022 Apr;40(4):517-526. doi: 10.1038/s41587-021-00830-w. Epub 2021 Feb 18.

    PubMed 33603203
  • Schmauch B, Herpin L, Olivier A, Duboudin T, Dubois R, Gillet L, Filiot A, Schiratti JB, Di Proietto V, Le Corre D, Bourgoin A, Taieb J, Emile JF, Fridman WH, Pronier E, Laurent-Puig P, Durand EY. A deep learning-based multiscale integration of spatial omics with tumor morphology. Nat Commun. 2025 Nov 27;16(1):11674. doi: 10.1038/s41467-025-66691-y.

    PubMed 41310346

Questions about this trial

What is this clinical trial studying?

An observational study of Diffuse Large B Cell Lymphoma and Solid Tumor Cancer, run by OWKIN at 5 sites in 4 countries.

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 12 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, United States, France, 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT06625203, which also lists 8 linked publications.

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 28 Sep 2026.

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