Inclusion Criteria:

• Age ≥ 16 years
• For cancer patients:
  • 100 samples from different cancer types, solid or blood tumors. We expect we’ll have the largest number of breast cancer patients as mentioned above.
  • Stages II, III, or IV disease.
• Provide written informed consent.
• Willingness to provide blood samples for neoantigen validation and T-cell activity assays.
• Patients will either have the archived frozen/FFPE tissue or consented to give fresh tissue biopsy and blood samples to the study.  Alternatively, if tumor sequence data is already available from 14-004094 or other external sequencing source, that data can be used in the place of a newly collected or archived frozen/FFPE sample.  However, fresh blood must still be collected.

Exclusion Criteria:

• Immunocompromised patients including patients known to be HIV positive.
• Patients receiving systemic steroid therapy or any other immunosuppressive therapy ≤ 30 days prior to registration. NOTE: Inhaled steroids, low-dose corticosteroids (e.g. equivalent to or less than oral prednisone 10 mg daily), and steroid use for primary prevention of nausea per institutional guidelines are allowed.
• Patients who received radiation therapy to the planned biopsy site within 6 months.
• Recent chemotherapy is not an exclusion criterion.
• Patients will also be excluded based on tissue/RNA/DNA quality and quantity
  • If any of the following quality and quantity thresholds are not met, the patient will be excluded:
    • Tumor tissue cellularity equal to or greater than 30%;
    • There are ≥ 2 cores with passing cellularity;
    • ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs;  
    • < 10% of DNA fragments are smaller than 1 kb; and
    • Sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and standard RNAseq according to the Mayo sequencing core (note: kits and technologies change overtime, so these are not fixed numbers). Note that since long-read RNAseq is optional, poor long-read RNAseq data (if generated) quality is not an exclusion criterion.
• Pregnant women will not be allowed to enroll on this study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/11/2024. Questions regarding updates should be directed to the study team contact.