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Recruiting NCT06349642

NCT06349642 Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

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Clinical Trial Summary
NCT ID NCT06349642
Status Recruiting
Phase
Sponsor Mayo Clinic
Condition Early Stage Triple-Negative Breast Carcinoma
Study Type OBSERVATIONAL
Enrollment 324 participants
Start Date 2024-04-24
Primary Completion 2027-05

Trial Parameters

Condition Early Stage Triple-Negative Breast Carcinoma
Sponsor Mayo Clinic
Study Type OBSERVATIONAL
Phase N/A
Enrollment 324
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-24
Completion 2027-05
All Conditions
Early Stage Triple-Negative Breast Carcinoma Metastatic Bladder Urothelial Carcinoma Metastatic Cervical Carcinoma Metastatic Clear Cell Renal Cell Carcinoma Metastatic Colorectal Carcinoma Metastatic Endometrial Carcinoma Metastatic Esophageal Carcinoma Metastatic Liver Carcinoma Metastatic Lung Non-Small Cell Carcinoma Metastatic Malignant Skin Neoplasm Metastatic Malignant Solid Neoplasm Resectable Lung Non-Small Cell Carcinoma Early Stage Lung Non-Small Cell Carcinoma Resectable Malignant Solid Neoplasm Resectable Triple-Negative Breast Carcinoma Stage III Renal Cell Cancer AJCC v8 Stage IV Cervical Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8 Recurrent Cervical Carcinoma Recurrent Colorectal Carcinoma Recurrent Endometrial Carcinoma Recurrent Esophageal Carcinoma Recurrent Liver Carcinoma Recurrent Lung Non-Small Cell Carcinoma Recurrent Malignant Skin Neoplasm Recurrent Malignant Solid Neoplasm
Interventions
Biospecimen CollectionTissue Collection

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Brief Summary

This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.

Eligibility Criteria

Inclusion Criteria: Subjects must meet one of the following criteria: * Subjects suspected of or diagnosed with the following Stage IV/metastatic or recurrent malignancies: * Lung: Non-small Cell Lung Cancer (NSCLC) * Skin: Cutaneous Malignancy, excluding Uveal Melanoma * Esophageal Cancer * Cervical Cancer * Endometrial Cancer * Colon Cancer: Mismatch repair deficient (dMMR) CRC only * All solid tumors with high tumor mutation burden (TMB) * All solid tumors that are microsatellite instability high (MSI-H) * All mismatch repair deficient (dMMR) solid tumors * Liver Cancer * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line. OR * Subjects suspected of or d

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