Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)

Официальное название

Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies

Обзор

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.

Подробное описание

Elephas is researching mechanisms of cutting, sorting and imaging tumors that leave the 3D tumor microenvironment (TME), including its immune cells, intact. This allows qualitative and semi-quantitative identification and characterization of the ex vivo response to exposure of potential immunotherapy. The ex vivo response data will then be compared to the clinical real world response data to inform development efforts.

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 8 центров

• Mercy Hospital - FTS — Fort Smith
• Frederick Health Hospital — Frederick
• Mercy Hospital - SPG — Springfield
• Mercy Hospital - South — St Louis
• Mercy Hospital -STL — St Louis
• Mercy Hospital - OKC — Oklahoma City
• JPS Health Network — Forth Worth
• Baylor Scott and White Biorepository — Temple

Публикации

• 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. PMID 33937012
• 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. PMID 30032384

Идентификаторы

NCT: NCT07327489 · ELEPHAS-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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