RECRUITINGOBSERVATIONAL
Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Able and willing to provide willing to sign a consent form for participation
2. Age ≥18 years at time of consent.
3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
4. 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.
Who Should NOT Join This Trial:
1. 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.
2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
3. Pregnant person(s).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Able and willing to provide informed consent for participation
2. Age ≥18 years at time of consent.
3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
4. 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.
Exclusion Criteria:
1. 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.
2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
3. Pregnant person(s).
Treatments Being Tested
PROCEDURE
Biopsy
Subjects 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.
Locations (8)
Mercy Hospital - FTS
Fort Smith, Arkansas, United States
Frederick Health Hospital
Frederick, Maryland, United States
Mercy Hospital - SPG
Springfield, Missouri, United States
Mercy Hospital - South
St Louis, Missouri, United States
Mercy Hospital -STL
St Louis, Missouri, United States
Mercy Hospital - OKC
Oklahoma City, Oklahoma, United States
JPS Health Network
Forth Worth, Texas, United States
Baylor Scott and White Biorepository
Temple, Texas, United States