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Pelotonia Institute for Immuno-Oncology

Immune Oncology Retrospective Cohort Study

    The Immune Oncology Retrospective Cohort Study is co-led by Drs. Lang Li and Zihai Li. It is designed to promote immune-oncology and data science research. This study includes a retrospective cohort of cancer patients who received immunotherapy, specifically Immune Checkpoint Inhibitors (ICIs). Data on ~8,000 patients initiated on immunotherapy since October 2011 is currently available. Data elements belong to one of the following categories - demographics, clinical (diagnoses codes, medications, labs), and molecular. The more serious and known toxicities related to immunotherapies are also available, including myocarditis, colitis, pneumonitis, and hepatitis.

    The overarching hypotheses include:

    • 1. Estimating the relative frequency of cancer immune drug efficacy and adverse drug events.
    • 2. Socio-demographic, clinical, genetic, molecular and cellular risk factors are associated with treatment efficacy and adverse events to cancer immunotherapies

    The following steps apply to investigators interested in querying the data:

    • Step 1: new investigators will email Dr. Aditi Shendre (shen62@osumc.edu) to be added to the IRB protocol to gain access to the data. IRB protocol will be shared subsequently.
    • Step 2: investigators with medical center ids will be granted access to SCARLET, in which aggregated data can be queried.
    • Step 3: if the investigators research questions do not fit within the overarching hypotheses, or if the researchers want new data, an IRB amendment will be requested. Data access will be granted following the approval of the requested amendments.

    After you have been added as an authorized user on the IRB protocol, please follow the steps below to query data:

    • 1. Connect to OSUWMC network / VPN.
    • 2. Visit SCARLET query portal: researchregistry.osumc.edu.
    • 3. Log in with your Medical Center credentials.
    • 4. Fill out the access request form. This step registers you with Scarlet and notifies our team to give you access.
    • 5. Research IT will grant access and notify you.

    Authorship Guidelines

    If you plan to use this database in writing your manuscripts, the following guidelines should be followed:

    • 1. Authorship will be based on the ICJME recommendations and journal requirements.
    • 2. A list of potential authors for publications should be provided at the time of requesting data access (before publication in case of existing users).
    • 3. The cohort PIs and key personnel, namely Drs. Lang Li, Zihai Li, and Aditi Shendre, will be included as co-authors in the manuscripts.
    • 4. Acknowledgements: Key persons who do not qualify for authorship but whose contributions significantly facilitate the resultant publications will be identified in the acknowledgements.
    • 5. Funding: All resultant publications will acknowledge the CCSG, the PIIO and the Pelotonia community for funding support [and any OSUCCC Shared Resource utilized].
      • Suggested text: Research reported in this publication was supported by The Ohio State University Comprehensive Cancer Center (OSUCCC) and the National Institutes of Health (NIH) under grant P30CA016058. This research was made possible through resources, expertise, and support provided by the Pelotonia Institute for Immuno-Oncology (PIIO), which is funded by the Pelotonia community and the OSUCCC. We thank the PIIO and the Immune Monitoring and Discovery Platform for their expertise and contributions relating to collecting, processing, storing, and analyzing the clinical trial correlates outlined herein [if applicable].