Active — Not RecruitingNot Applicable

Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform

United States416 participantsStarted 2023-06-26

Plain-language summary

The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
✓. Age ≥ 18 years at the time of consent.
✓. Subjects must meet one of the following criteria:
✓. Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure
✓. 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

✕. Subjects who are pregnant
✕. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment
✕. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy
✕. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial

What they're measuring

Determine Ex-Vivo Prognostic Accuracy of Elephas Platform

Timeframe: 3 years

Trial details

NCT IDNCT05520099

SponsorElephas

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01

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