ROS1 PDX Study

ROS1-Fusion Positive Tumors for PDX Study

Christine M. Lovly, MD, PhD
Vanderbilt-Ingram
Cancer Center

ROS1-fusions occur in several cancer types – non-small cell lung cancer, gastric cancer, ovarian cancer, glioblastoma, cholangiocarcinoma, melanoma, and others. In each of these cancers, ROS1-fusions account for a small sliver of the pie, accounting for approximately 1-2% of all diagnoses, resulting in a relatively rare yet critically important molecular subset of cancer. The Addario Lung Cancer Medical Institute (ALCMI) is focusing efforts on this under-studied molecular subset of cancer to understand what drives tumor formation, therapeutic response, and acquired therapeutic resistance. Therefore, in support of cancer patients whose tumors have ROS1-fusions, we are launching a global effort to study ROS1-fusions across all tumor types.

Click on topic below for more information.

Note that this study is now closed to enrollment.

Study Purpose

Patient Derived Xenografts (PDXs) are models to study cancer. These models are developed by implanting a fresh piece of tumor specimen from a patient into a special type of mouse, which has a limited immune system. These mice act as ‘hosts’ to allow the tumor to grow. Numerous peer-reviewed and published experimental studies have now shown that PDX models maintain features similar to the original tumor from the patient. PDX models can be used to study tumor growth, response to anti-cancer therapies, and resistance to anti-cancer therapies.

The purpose of this study is to develop at least 24 PDX models for ROS1-fusion driven cancers to be used for research purposes only. That is, these patient derived PDX models will have no immediate benefit to the patient from whom the tumor specimen was obtained. Rather, these PDX models will be used to inform the study of ROS1-fusion driven cancers at large.

We are working with Champions Oncology, a company that specializing in PDX models, to create PDX models from ROS1-fusion driven cancers. To learn more about Champions Oncology, visit their website at https://championsoncology.com/.

What is a PDX Mouse Model?

The Champions Oncology team will implant and grow a piece of a patient’s live tumor in immune-deficient mice. With the Champions technology, the PDX tumor can maintain the characteristics of the patient’s tumor, with all of its different cells and connective tissue, inside a living environment (an immune deficient mouse). The resultant PDX models will be used in the future for research to understand how cancer begins and spreads in these tumors, how these tumors respond to treatment and what happens when tumors stop responding to treatment.

The process begins with a piece of your live tumor, so it is best to plan in advance of your biopsy or surgical procedure.

The process is simple:

What Should You Expect in This Study

The research study has certain requirements that must be met. If you do not meet the requirements, you will not be able to participate in this research study.

The process begins when you have a surgery or biopsy of your ROS1-fusion cancer scheduled. You will speak with a member of our study team to learn about the study activities. After you speak with our team, you will be provided with an informed consent form to review. The consent form explains this research study in detail. You will also provide us with a copy of your pathology and molecular analysis reports to determine your eligibility for this study.

If you are eligible for the study, you will work with the Champions Oncology team to coordinate the collection and shipment of your tumor to their facility. It is very important that you work in collaboration with the Champions team.

You will call your physician/surgeon and let them know that you want to donate a portion of your tumor to this research study and that Champions Oncology will be in contact with them.
You will be provided a letter to give to your physician/surgeon notifying them of your participation in this research study.
You will be in contact with Champions Oncology team as they attempt to train your physician/surgeon on the collection and shipment procedures.

How To Participate

Individuals with a ROS1-fusion positive cancer living anywhere in the US (including Alaska, Hawaii and Puerto Rico) and Canada can participate in this study, if eligible. We are working to open the study to individuals in other countries in the coming months.

The first step is to complete the Contact Form. A member of our study team will contact you to schedule a time to review the eligibility requirements and study activities. If your biopsy or surgical procedure is scheduled within the next 3 days, complete the Contact Form and call our study team at 866-988-ROS1 (7671).
The study team will review the pre-screening questionnaire and, if you meet the pre-screening requirements, you will be provided access to the consent form.

Contact Form

Thank you for your interest. This study is now closed to enrollment.