A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.

Обзор

The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs) across multiple oncological indications by comparing the results to actual treatment responses for cancer patients.

Подробное описание

The Episwitch CiRT® (Checkpoint inhibitor Response Test) predicts how a patient will respond to immune checkpoint inhibitor (ICI) therapies by delivering a binary response likelihood profile (High Probability vs. Low Probability).

Patients who have been diagnosed with stage III and IV cancer and who are candidates and/or planned to receive immune check point inhibitors as a therapy now or in near future will be offered the Episwitch CiRT™ before starting treatment or if on active treatment. Those patients with high probability of response to ICI will undergo repeat testing every three months. Patients will be followed for up to six months. Treatment administered, disease-free survival, overall survival, stable disease, progressive disease, complete response, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded for six months. Comprehensive data of Social Determinants of Health (SDoH) will be collected to identify any correlation to unmet Health Related Social Needs (HrSN) and likelihood to response and/or resistance

Первичные конечные точки

• Correlation between low probability of response prediction and actual response rate to Immune Checkpoint Inhibitor Therapy [Срок оценки: From enrollment to the final Episwitch test at week 24]
• Establish Health Economics Outcomes Research based on the potential cost savings from foregoing ICI therapy based on Episwitch CiRT prediction of response [Срок оценки: From time of enrollment to the 24-week follow up test results]
• Determine the existence of a correlation between Social Determinants of Health and test results and patient outcomes [Срок оценки: From time of enrollment to the 24-week follow up test results]

Критерии участия

Критерии включения

• 18 years of age or older
• Stage III or IV cancer
• Selected by their healthcare provider to receive the Episwitch CiRT® test according to the current evidence-based schedule (per protocol) as part of their standard of practice.
• ECOG performance status ≤ 2
• Clinically eligible for ICI therapy
• Able to read, understand and provide written informed consent.
• Willing and able to comply with the study requirements

Критерии исключения

• Pregnant or breastfeeding
• History of bone marrow or organ transplant
• Contra indication for receiving Immune Check Point inhibitor.

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 · 3 центра

• Eastern Connecticut Hematology and Oncology — Norwich
• Cancer Center of Middle Georgia — Dublin
• Carolina Blood and Cancer Care Associates — Rock Hill

Идентификаторы

NCT: NCT06635954 · OB202401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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