What this study is
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.
What's being tested
- Biopsy
Intervention · PROCEDURE
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.
Study details
- Official title
- Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
- Sponsor
- Elephas
- Conditions
- Cancer · Immunotherapy · Advanced Solid Tumors Cancer · Bladder Cancer · TNBC, Triple Negative Breast Cancer · Colorectal Cancer · DMMR Colorectal Cancer · MSI-H Colorectal Cancer · Endometrial Cancer · Head and Neck Cancer · Kidney Cancer · Liver Cancer · NSCLC (Non-small-cell Lung Cancer) · Skin Cancer · Melanoma (Skin Cancer)
- Enrolling
- 2,000 people
- Starts
- 2025-04-14
- Est. completion
- 2038-04
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
8 openMercy Hospital - FTS
Fort Smith, Arkansas, United States
- Billy Cater · Contact479-314-5089billy.cater@mercy.net
- Aswanth Reddy, MD · Principal investigator
RecruitingFrederick Health Hospital
Frederick, Maryland, United States
- Ingrid Halvorson · Contact301-662-8477ihalvorson@frederick.health
- Heather Chalfin, MD · Principal investigator
RecruitingMercy Hospital - SPG
Springfield, Missouri, United States
- Hanna Dulier, RN. BSN · Contact4178203891hanna.dulier@mercy.net
- Mohan Tummala, MD · Principal investigator
RecruitingMercy Hospital - South
St Louis, Missouri, United States
- Danielle Werle, RN, BSN · Contact3145256042danielle.werle@mercy.net
- Yifan Tu · Principal investigator
RecruitingMercy Hospital -STL
St Louis, Missouri, United States
- Alesia Bell · Contact(314) 251-4400alesia.bell@mercy.net
- Nancy Umbeck · Contactnancy.umbeck@mercy.net
- Bethany Sleckman · Principal investigator
RecruitingMercy Hospital - OKC
Oklahoma City, Oklahoma, United States
- Trisha Stubhar · Contact405-751-4343 ext. 4057523401trisha.stubhar@mercy.net
- Carla Kurkjian · Principal investigator
RecruitingJPS Health Network
Forth Worth, Texas, United States
- April Bell, MS, CCRC, ACRP-PM · Contact817-702-8254ABell01@jpshealth.org
- Paras Patel · Principal investigator
RecruitingBaylor Scott and White Biorepository
Temple, Texas, United States
- Vanessa Hoelscher · Contact254-724-6759vanessa.hoelscher@bswhealth.org
- Mathew Bower, MD · Principal investigator
Not yet recruiting
Study team
Sponsor
Elephas
Study ID ELEPHAS-05
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.