Clinical Trial TitlePilot feasibility study evaluating the clinical validity of tumor organoid drug screens
Clinical Trial Protocol Description:
This is a prospective, pilot biomarker correlative study. The purpose of this study is to determine the ability to create tumor organoids and evaluate the organoid response to anti-cancer therapies (drugs) in different types of advanced or metastatic cancer.
A tumor organoid is a three-dimensional, smaller amount of tumor tissue that is grown in a lab based off the patient’s own tumor characteristics. A tumor organoid is created from a fresh biopsy (removal of tissue) of a patient’s tumor. “Metastatic” means tumor tissue that has spread from the original site or from an unknown site to a distant region/organ in your body.
We will also perform genetic tests on the tumor biopsy and organoid to study the tumor’s potential response to treatment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have known or strong suspicion for metastatic malignancy.
- Have measurable disease by RECIST criteria and cannot have bone only metastatic disease.
- Are at least 18 years of age.
- Are able to undergo a soft tissue (non-bone) research biopsy as deemed clinically appropriate by physician.
- Plan to proceed with first line or next line of a commercially-available systemic therapy after completion of research biopsy.
- Are willing to undergo research biopsy prior to initiation of first line or next line of therapy for metastatic disease or upon progression of disease and prior to starting next line of therapy.
- If patient also undergoing diagnostic biopsy to establish metastatic disease, then additional tissue will be required for study participation. Eligibility will be determined by the proceduralist to assess safety of additional research tissue collection.
- Are planning to undergo first or next line of therapy at RUSH University System for Health, including drug administration, follow up imaging, and blood draws.
- Are able to sign consent prior to enrollment to document willingness to participate in the study.
- Inclusion of women and minorities
You will be excluded from the study if any of the following criteria apply to you:
- Are unable to safely undergo research biopsy as deemed by proceduralist.
- Are not willing to undergo research biopsy.
- Initiate your own next line of treatment prior to completion of research biopsy.
- Do not plan on starting a new systemic chemotherapy after research biopsy completed.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.