About this trial
This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to provide informed consent for participation
Age ≥18 years at time of consent.
Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.
Disqualifiers
Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.
Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
Pregnant person(s).
Trial population
Adults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.
Trial design
Cohort
Prospective
Treatments tested in this trial
Biopsy
Procedure/SurgerySubjects must be clinically able, at investigator discretion, to undergo additional biopsy passes during their biopsy. Biopsy specimen(s) will be obtained during a standard of care (SOC) procedure. If a subject receives a subsequent SOC biopsy for clinical diagnosis purposes, additional sample(s) may be collected and sent to the Sponsor.
Treatment groups
Trial outcomes
Primary outcomes
Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging
Collect human tumor specimens to research mechanisms of tumor cutting, imaging, and ex-vivo immunotherapy treatment response, while maintaining cell stability in a live tumor microenvironment.