Total Cancer Care (TCC)
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A common protocol used by ORIEN member sites (back to top)
ORIEN members utilize a common protocol, Total Cancer Care. Total Cancer Care represents a true partnership with patients who donate their clinical data and biospecimens so that we may learn from their experiences and develop evidence-based approaches to meet their needs.
The Total Cancer Care protocol (TCC) provides a standard system for consent, biospecimen collection, tracking of patient demographic, molecular, clinical, and epidemiological data throughout a patient’s care, and potentially lifetime. The lifetime consent also allows for re-contacting patients to notify them about opportunities to participate in clinical trials for which they are eligible. The broad mission of the Total Cancer Care protocol is to support cutting edge translational research to advance the prevention, diagnosis, and treatment of cancer. To date, OSU has enrolled nearly 70,000 patients into TCC, and nationwide, over 385,000 patients have consented to the protocol. A subset of over 27,000 cancer patients enrolled in Total Cancer Care ORIEN-wide are part of the ORIEN Avatar cohort which includes research grade next generation exome sequencing of tumor and normal tissue and RNAseq of the tumor. Over 5,000 OSU Total Cancer Care patients are part of the Avatar cohort and this molecular data is available to OSUCCC researchers along with clinically annotated data.
What is available from TCC at OSU?
- Biospecimens including frozen tissue (tumor and adjacent normal), plasma, serum, DNA, tissue from FFPE and some additional non-invasive specimens such as buccal swabs, stool, etc.). Note: not all patients have associated specimens.
- Clinical data (sources include EPIC, James Cancer Registry and other clinical platforms such as those for radiation oncology, radiology, digital pathology). Clinical data are provided as de-identified, coded limited or PHI depending upon the request. Note: PHI requires an additional IRB-approved protocol.
- Raw or processed genomic data and associated clinical data for OSU cases in the ORIEN Avatar project
- Opportunity to coordinate consent to other protocols to utilize specimens and data across both protocols.
- Consenting, procurement, processing, banking and distribution are funded by TCC. There is no charge to investigators.
- Letters of support for grants.
- How do I request TCC specimens or data?
- Use this link: https://go.osu.edu/osutcc
What is the process once I complete my request?
- A TCC project manager will review your request and follow-up with any questions/clarification needed.
- The TCC team will assess feasibility and determine if the TCC has the number of patients/specimens requested.
- The TCC Research Committee will review requests.
- Once approved by the research committee, the TCC team will begin fulfilling the request.
- Please note: frozen specimens come from the TCC Biorepository. FFPE material will come from Pathology Tissue Archive Services—requesting FFPE material will add time to fulfillment.
For additional information on Total Cancer Care, please contact Laura Monovich, MBA, TCC Operations Director (laura.monovich@osumc.edu)
What are the opportunities with ORIEN?(back to top)
- Collaborative projects with other ORIEN members
- Projects are submitted locally prior to submission to the ORIEN Network. You may propose a project by using this link: https://osu.edu/orien-intermember-request
- Once approved locally by the TCC Research Committee, the TCC team will submit the project summary to the ORIEN Scientific Team.
- The researcher will be invited to present for approximately 10-15 minutes to the ORIEN Scientific Committee (template provided).
- Once approved by the ORIEN Scientific Committee, the ORIEN Scientific Team will send the project summary and slides to member institutions.
- Member institutions may opt in or out.
- A summary of members who agreed to participate will be provided to the investigator.
- Please note that currently, most intermember projects use ORIEN Avatar genomic and/or clinical data. This is provided free-of-charge to investigators as long as no more than 3 downloads are required.
- If researchers are proposing a project that would include biospecimens or data not in the Avatar clinical data, then they generally would need to provide some funding to help offset costs at member sites.
- Research Interest Groups
- ORIEN has a growing number of Research Interest Groups (RIGS) that hold periodic meetings to collaborate across member institutions on projects and publications.
- ORIEN holds a scientific meeting once a year.
For additional information on ORIEN, please contact Nancy Single, PhD, Director, Clinical Research Operations (Nancy.single@osumc.edu)
TCC FAQ (back to top)
How do I request access to TCC specimens and data?
Please use the following link to make your request, https://go.osu.edu/osutcc
A how to make a request video is located here: https://osu.zoom.us/rec/share/vwg8AWF1JB0dddmEa4qMbw1VecK2l-cI9jwb8gPj4Bpw7rT0kE_FbYWBF0OWh402.Uifhwk86RmdJIIyp?startTime=1680200537000
What is available through TCC?
- Biospecimens (including but not limited to frozen tumor/normal tissue; plasma, serum, DNA, FFPE)
- Clinical data from the James Cancer Registry and Epic (the EMR)
- Research-grade genomic sequencing data – WES and RNA Seq (raw and processed) and a clinical dataset on a subset of TCC patients
- Letters of support for projects and grants
What is the cost associated with a TCC request?
There is no cost at this time.
Can clinical & molecular data requests be refreshed over time?
- Current IRB-approved studies can receive refreshed data.
- De-identified and coded limited data requests are not eligible for updates after 90 days per medical center clinical data policy.
What are the molecular data file types available?
RNA-Seq data files include (per sample):
- FASTq
- CRAM, CRAI
- Gene expression
- Isoform expression
- Fusion predictions (STAR fusion & Arriba)
- Fusion prediction pdf files
WES data files include (per sample):
- FASTq
- CRAM, CRAI – tumor and normal
- Recalibration table
- .g.vcf file
- VCF – tumor and normal
- Paired Mutect2 VCF
- Annotated somatic and tumor VCF (by Funcotator and Aster PoN)
- MSIsensor2 output (.tar compressed)
- Sequenza somatic CNV output
- Segments, seqz intermediate files
- Graphical CNV outputs at chromosome and genome levels
- Per gene CNV calls
- scarHRD per T/N pair
Can I have access to the processed files? Yes
Can I have access to the raw files? Yes
Once I receive the email from TCC that my molecular data is available, how long do I have to download it? 45 days
Can TCC analyze my molecular data request?
No, but we can connect with a bioinformatician if you are not already working with one.
Can TCC transfer my molecular data files to OSC?
No, that would be done by you/your lab.
How much storage space should I have for the molecular data?
That will depend upon the size of the request and type of data requested (e.g., processed vs. raw). The TCC team can advise.
I have submitted my data/specimen request. How long will it take for me to receive the specimens and/or data?
Timelines for completion of data/specimen requests varies based on the specifics of each request (number of patients, volume and types of data and specimens).
Factors that influence fulfillment time include:
- the number and types of specimens being requested,
- the number and of patients on whom data is being requested,
- investigator response time for questions and clarifications related to the request,
- the number of other TCC requests currently in the queue
- if FFPE material is being requested, that will have an impact on fulfillment time due to look-up time and dependency on pathology tissue archive services to retrieve the material.
A summary of the current stage of the process that your request is in can be found at [link to REDCap request summary]
A how to make a request video is located here: https://osu.zoom.us/rec/share/vwg8AWF1JB0dddmEa4qMbw1VecK2l-cI9jwb8gPj4Bpw7rT0kE_FbYWBF0OWh402.Uifhwk86RmdJIIyp?startTime=1680200537000
What are some tips to make my request go faster?
- Provide clear inclusion/exclusion criteria for the cases for your project. If you have an approved IRB protocol associated with the study and can provide patients that you know fulfill the requirements of the project at the time of submission, then the amount of time spent in the case-finding process can be significantly reduced.
- Respond to questions from TCC staff regarding the project in a timely manner. We are always happy to have a call if that is easier and more efficient.
- If you have a specific timeline by which you need data/specimens, provide that information as part of your request. TCC staff can estimate whether or not the timeline is practical based on previous experience.
- If there are specific guidelines for tissue requests (such as tissue for an external institution, etc.) provide those guidelines in the request.
- Many requests experience considerable delays waiting on completion of an MTA/DUA. It may be beneficial to have started the MTA before submitting a request to the TCC.
What kinds of data can I request from the TCC?
The TCC has access to many data points available from the Cancer Registry and Epic, the electronic medical record. The data provided are based on the request—there is not a “standard” dataset for TCC patients. Some data points are not discretely captured in the medical record; accordingly, these data may require a separate chart review on the investigator’s part.
There is a standard clinical dataset for ORIEN Avatar patients.
Can I request a letter of support?
Yes, please use the following link to make your request, https://go.osu.edu/osutcc. Please submit a request at least one week in advance and include a draft letter, the funding source, and the type of funding.