Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies
NCT ID: NCT07327489
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2025-04-14
2038-04-30
Brief Summary
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Detailed Description
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This study will collect tumor specimens from patients with suspected or confirmed cancer. These specimens, along with clinical data and genomic data obtained as part of a patient's standard of care, will be used to perform this research.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
3. Pregnant person(s).
18 Years
ALL
No
Sponsors
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Elephas
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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References
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Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021.
Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1.
Other Identifiers
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ELEPHAS-05
Identifier Type: -
Identifier Source: org_study_id
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