Advanced Solid Tumors Cancer, Bladder Cancer, Cancer, Colorectal Cancer, DMMR Colorectal Cancer, Endometrial Cancer, Head and Neck Cancer, Immunotherapy, Kidney Cancer, Liver Cancer, Melanoma (Skin Cancer), MSI-H Colorectal Cancer, NSCLC (Non-small-cell Lung Cancer), Skin Cancer, TNBC, Triple Negative Breast Cancer
Conditions
Keywords
Immunotherapy, Live Tumor Biopsy, Elephas, Cancer, Imaging, Tumor Cutting, Treatment Response, Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
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.
Detailed description
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.
Interventions
PROCEDUREBiopsy
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.
Sponsors
Elephas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging | Study duration is approximately 36 months from enrollment to end of study. | Collect human tumor specimens to research mechanisms of tumor cutting, imaging, and ex-vivo immunotherapy treatment response, while maintaining cell stability in a live tumor microenvironment. |
Countries
United States
Outcome results
None listed