RecruitingNCT07327489

Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies


Sponsor

Elephas

Enrollment

2,000 participants

Start Date

Apr 14, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria3

  • 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).

Interventions

PROCEDUREBiopsy

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

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NCT07327489


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