ENIGMA Study

ENIGMA+ A Study of Advanced ALK+ Non-Small Cell Lung Cancer (NSCLC)

Justin F. Gainor, MD
Massachusetts General Hospital

Jessica J. Lin, MD
Massachusetts General Hospital

Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)

ALK-positive lung cancer is a subtype of lung cancer which carries a genetic change in a gene called ALK (anaplastic lymphoma kinase). About 5% of lung cancers are ALK-positive. These ALK-positive lung cancers carry a genetic change which results in an abnormal ALK protein that tells the cancer to grow.

The purpose of this research study is to obtain and study tissue, saliva, and blood specimens from patients with ALK-positive lung cancer, along with clinical information about their disease and treatment.

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Study Purpose
In this research study, we are obtaining and studying tumor, saliva, and blood specimens from patients with advanced ALK-positive lung cancer, and also collecting clinical information. The overall goal is to enhance understanding of the biology of ALK-positive lung cancer.
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 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 medical record and pathology report indicating that your cancer is non-small cell lung cancer (NSCLC), and a copy of your genomic testing report showing that your cancer is ALK-positive (ALK+).

If you are eligible for the study, you will work with our study team to complete the following tasks:

Intake Form – The questionnaire reflects the inclusion/exclusion criteria and requests your contact information, emergency contact information, and the treating physician’s contact information. This will allow the study team to keep your treating physician aware of your voluntary participation in this research.
Medical Release Form – This document gives the study team permission to obtain and review your medical records pertaining to any personal history you have of cancer. This will allow us to further confirm your eligibility for this study.
Archival Tissue – A biopsy is not required to participate in this study. Archival tissue, defined as tumor tissue collected during a standard of care procedure and stored at your treating institution, will be collected when available. We seek to collect a portion of all available previously collected tumor tissues, as well as, a portion of any tumor tissue collected, during a standard of care procedure prescribed by treating physician(s), during the course of your study participation. The study team will work with you and your treating institution to identify available tissue specimens.
Saliva Collection – The study team will coordinate the collection of saliva once your enrollment has been confirmed and at least one archival tumor tissue has been confirmed as available for collection. Only one saliva specimen will be collected for this study unless the collected specimen proves of insufficient quality on testing.
Follow Up for 2 Years – We would like to track your medical condition for up to two years. We would like to do this by contacting you every 3 months for the first year and every 6 months for the second year. Keeping in touch with you and checking your condition helps us look at the long-term effects of the research study. So that we can be sure to reach you, we ask that you provide contact information for a family member who we can contact if we are unable to reach you.
How To Participate
Individuals with ALK-positive lung cancer living anywhere in the US (including Alaska, Hawaii and Puerto Rico) can participate in this study, if eligible.

  1. 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. Or you can call the ENIGMA+ study team at 866-694-4ALK (866-694-4255).
  2. The study team will review the eligibility requirements with you and, if you meet these requirements, you will be provided access to the Informed Consent Form.
Contact Form
ENIGMA Study
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