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

Launched by ELEPHAS · Aug 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new diagnostic tool called the Cybrid live tumor diagnostic platform, which aims to help doctors better understand and predict how solid tumors, like certain cancers of the colon, lung, skin, and kidney, might respond to treatment. The main goal is to see how accurately this tool can assess tumor characteristics compared to standard methods of evaluation. The trial is currently recruiting participants aged 18 and older who have been diagnosed with specific advanced cancers, such as stage III or IV urothelial carcinoma or clear cell renal cell carcinoma, or stage IV colorectal, head and neck, lung, skin, or endometrial cancers.

If you or a loved one are interested in participating, you would need to provide consent and be willing to undergo a separate biopsy procedure to collect tissue samples. This study is looking for individuals who are newly diagnosed and have not started treatment yet, although some criteria allow for those who may have had prior biopsies. It's important to note that participants should not be pregnant, and those with certain autoimmune diseases or who are immunocompromised may not be eligible. By joining this trial, participants could contribute to the development of a promising new tool that may improve cancer treatment in the future.

Gender

ALL

Eligibility criteria

• • 1. 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.
• • 2. Age ≥ 18 years at the time of consent.
• 3. Subjects must meet one of the following criteria:
• * Subjects suspected or diagnosed with Stage III or IV:
• • Bladder: Urothelial Carcinoma (UC)
• • Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)
• * Subjects suspected or diagnosed with Stage IV/metastatic:
• • Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC)
• • Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers
• • Lung: Non-small cell lung cancer (NSCLC)
• • Skin: Cutaneous Melanoma, excluding Uveal Melanoma
• • Uterus: endometrial cancer
• * Subjects suspected or diagnosed with:
• • Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy.
• • Any metastatic solid tumor that the clinician plans to treat with ICI therapy. NOTE: This can be either in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line.
• • 4. Subjects must be clinically able, at investigator discretion, to undergo additional core needle or forceps biopsy passes during their biopsy.
• • 5. 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.
• • 6. Subjects with a newly confirmed diagnosis who have previously undergone a standard of care biopsy must be willing to undergo a separate biopsy procedure solely for the purposes of this study.
• • 7. Female subjects must not be pregnant.
• • 8. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment are not eligible.
• • 9. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy are not eligible. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
• • 10. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial are not eligible.