SUCCEED Study
SUCCEED – A Pilot Study for Patients with Small Cell Lung Cancer (SCLC)
Christine Lovely, MD, PhD
Vanderbilt-Ingram Cancer Center
SUCCEED: Small Cell Lung Cancer Community Engagement to Eliminate Research Disparities
This initial ‘pilot’ research study is designed to evaluate the feasibility of conducting a remote, decentralized USA bio-specimen (blood sample) collection trial in adult patients diagnosed with SCLC.
Another important aim of the study is to identify potential barriers to trial participation, and to identify supportive resource gaps – as self-reported by study participants.
After initial eligibility and consenting into the study, trial volunteers will complete a short survey at enrollment and again at month 4. The research team will also coordinate to collect a blood specimen for storage at a biorepository for future research. You do not have to visit our facility to participate. All study procedures will be performed remotely. You do not have to change your current primary physician(s) to participate.
You are invited to take part in this research study, because you have small cell lung cancer (SCLC) – either newly-diagnosed or transformed from another lung cancer type. This is a non-treatment, non-interventional, and non-randomized study. No experimental product or procedure is involved.
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Study Purpose
In this research study, we will collect a blood specimen and submit it for storage at a biorepository for future research. The biorepository company is called, Precision for Medicine (Norton, MA). This company specializes in storing bio-specimens. Aims of the study include evaluate logistical and resource barriers for patients with SCLC to successfully participate in research trials. The SUCCEED study hopes to identify potential solutions to trial participation barriers, as volunteered by study participants.
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 the study team to learn about the study activities. After you speak with the study team, you will be provided with an informed consent form to review. The consent form explains this research study in more detail. You will also provide us with a copy of your molecular analysis (tumor pathology) report and medical records indicating that your cancer is of small cell form, to determine your eligibility for this study.
If you are eligible for the study, you will work with the study team to complete the following tasks:
Study Intake Form – The form 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 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.
Blood Specimen – You will provide a small amount of blood, (approximately 1-2 tablespoons or 20 mL). We will ship a blood collection kit to your home. You can bring this kit to a medical provider or local laboratory of your choice for collection of the blood specimen or request the study team to send a phlebotomist directly to your home for this blood collection.
- All blood collected (approximately 2 tubes of 8-10ml each) will be returned to the study team at Precision for Medicine (biorepository) using pre-paid and pre-labeled shipping materials that are provided.
- Both tubes of the blood will be saved for future studies. Because any future studies are exploratory, you will not receive those results back.
Medical Records – We will collect copies of pathology reports from any prior tumor biopsies, imaging reports (CT scans, MRIs, X-rays, and bone scans), genomic testing reports, and medical records.
Follow Up for 4 Months – We would like to survey your participation experience at entry to the study, and again at four (4) months later.
How To Participate
Individuals with SCLC lung cancer living anywhere in the US (including Alaska, Hawaii and Puerto Rico) can participate in this study, if eligible.
- 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.
- The study team will review the Contact Form and, if you appear to meet the study requirements, you will be provided access to the Intake and Consent forms.
