Immune Response to Antigens
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 21-007742
Sponsor Protocol Number: 21-007742
About this study
The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Age > 18 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.
- 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.
- Patients will either have the archived frozen 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, that data can be used in the place of a newly collected or archived frozen sample. However, fresh blood must still be collected.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 11/15/22. Questions regarding updates should be directed to the study team contact
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Yan Asmann, Ph.D.
Open for enrollment
Yan Asmann Ph.D.
Publications are currently not available