Recruiting

Observational Study

Sponsor:

Elephas

Code:

NCT07327489

Conditions

Cancer

Immunotherapy

Advanced Solid Tumors Cancer

Bladder Cancer

TNBC, Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Study Details

Brief 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.

Conditions

Cancer

Immunotherapy

Advanced Solid Tumors Cancer

Bladder Cancer

TNBC, Triple Negative Breast Cancer

Study ID

NCT07327489

Start date

Apr 14, 2025

Status verified date

Jun, 2026

Completion date

Apr, 2038

Anticipated

Primary completion date

Apr, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Study 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.

Interventions

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.

Primary outcome measure

  • Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging [ Time Frame: Study duration is approximately 36 months from enrollment to end of study. ]

Central Contacts and Locations

Locations

Mercy Hospital - FTS

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Billy Cater

479-314-5089billy.cater@mercy.net

Principal Investigator:

Aswanth Reddy, MD

Frederick Health Hospital

Recruiting

Frederick, Maryland, United States, 21702

Contacts

Ingrid Halvorson

301-662-8477ihalvorson@frederick.health

Principal Investigator:

Heather Chalfin, MD

Mercy Hospital - SPG

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Hanna Dulier, RN. BSN

4178203891hanna.dulier@mercy.net

Principal Investigator:

Mohan Tummala, MD

Mercy Hospital - South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Danielle Werle, RN, BSN

3145256042danielle.werle@mercy.net

Principal Investigator:

Yifan Tu

Mercy Hospital -STL

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Alesia Bell

(314) 251-4400alesia.bell@mercy.net

Nancy Umbeck

nancy.umbeck@mercy.net

Principal Investigator:

Bethany Sleckman

Mercy Hospital - OKC

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Trisha Stubhar

405-751-4343trisha.stubhar@mercy.net

Principal Investigator:

Carla Kurkjian

JPS Health Network

Recruiting

Forth Worth, Texas, United States, 76104

Contacts

April Bell, MS, CCRC, ACRP-PM

817-702-8254ABell01@jpshealth.org

Principal Investigator:

Paras Patel

More Information

Sponsor

Elephas

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Immunotherapy
  • Live Tumor Biopsy
  • Elephas
  • Cancer
  • Imaging
  • Tumor Cutting
  • Treatment Response
  • Core Needle Biopsy
  • Forceps Biopsy
  • Punch Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Elephas on 2026-06-29.