Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Description

The purpose of this research study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

A genetic test will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. All tissues in the body are made up of cells. Those cells contain DNA, which is your unique genetic material that carries the instructions for your body’s development and function. Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs. We are interested to see if your tumor tissue might have one of the following two genetic changes:

• Genetic changes in ALK (this will be referred to as ALK )
• Genetic changes in EGFR (this will be referred to as EGFR)

ALK and EGFR are both proteins found on the surface of cells. If your tumor is found to have one of these genetic changes you may be invited to participate on a trial that will look at drugs which may target tumors that have these specific genetic changes.

If your tumor is not found to have the genetic changes in ALK or EGFR, your doctor will provide you with other options for your care and you will be followed for 5 years. A doctor or research staff will contact you every 6 months for 5 years to determine the status of your cancer and your overall health. This will help doctors better understand what happens to patients receiving the standard treatment for the disease.

Another purpose of this research study is to learn more about cancer and why treatments may be more effective or even stop working with some tumors or in certain patients. After your tumor tissue is screened, if there is any tissue left, the remainder of your coded tissue samples will be sent to a National Cancer Institute (NCI)-sponsored storage facility, currently known as the Biospecimen Core Resource (BCR). The samples will be processed there and portions of your samples then will be sent to different types of laboratories, all within the NCI facility, as part of this project. Additionally, if your cancer comes back and there is biopsy tissue available for analysis, this too will be studied in that way. One type of laboratory will analyze your DNA by a method called sequencing. Other types of laboratories will study other biochemical material from your samples by different methods. The remaining portions of your samples, if any, will be stored at the BCR for possible future use in research related to cancer or, perhaps, in other research projects.

Details