USCLC Registry

Welcome to the USCLC Registry

Specifically, our goals for the USCLC Registry are the following:

1. To determine the incidence and geographic locations of patients with the various subtypes of cutaneous lymphoma in the US
2. To determine and validate factors for each type of cutaneous lymphoma that may affect prognosis including those related to:
   1. Staging
   2. Pathologic and molecular features of skin, lymph nodes, bone marrow or internal organs
   3. Radiologic characteristics including various types of imaging
   4. Blood tumor burden or blood markers of significance
3. To determine the efficacy of various treatments or interventions (monotherapies or in combination) for patients with each subtype of cutaneous lymphoma
4. To enable patients with the various subtypes of cutaneous lymphoma to input data on the effect of their disease and treatment(s) on their and their families' quality of life
5. To enhance the communication between patients with cutaneous lymphoma and the physicians directing their care

1. To compare and contrast treatment algorithms between study sites
2. To develop and validate new quality of life metrics for patients with cutaneous lymphoma
3. To develop meaningful outcome measures that are of value to physician and patient alike
4. To provide a platform for clinical trials of patients with cutaneous lymphoma to facilitate collaborative research with other national and international organizations
5. To encourage development of a virtual tissue bank and studies on potential biomarkers of each cutaneous lymphoma subtype by encouraging collection of blood/tissue at sites who are participating in the clinical registry
6. To educate physicians, by their participation in this registry, with best current approaches and treatments of these cutaneous lymphomas and to encourage participation in research studies of same

• What is the platform for the Registry?
  The platform is a secure, cloud-based platform created and maintained by Answers Ahead. Answers Ahead is a company focused on creating secure, cost efficient data management solutions for multi-site studies.
• Who are the contributors to the Registry?
  The Registry is open to all current Active members of the USCLC who are based in the United States. We are actively working on a plan for our International members. All members must first sign a Site Agreement with the USCLC and have IRB approval at their site for the central protocol and informed consent form.
• Who owns the data?
  The data that are put in at each site are jointly owned by that site and the USCLC. This allows the site to have its own database as well as the USCLC to own all the aggregate data at all sites.
• Who may use the data?
  The USCLC Registry Committee determines how the aggregate data are used and published. Each site may use its own data for whatever purposes it wishes but any publication or new research involving sharing of data must first be approved by the USCLC Registry Committee to prevent duplication of efforts already planned or undertaken by the USCLC.
• How is the Registry funded?
  The USCLC Registry is funded through profits from USCLC sponsored meetings and grants from industry, foundations, NIH, and individuals. All grants are made for unrestricted USCLC or USCLC Registry use without any ties to use or have direct access to our data. The USCLC does not at this time charge Active US Members an additional fee to use the USCLC Registry Platform.
• Does the USCLC pay sites to enter data or otherwise support financially regulatory requirements?
  The USCLC is generously paying for the platform and maintenance of the site for all USCLC Active Members. This is up to $3500 per year per site to start and $3000 per year per site to maintain the platform. There are no additional monies available for entering data at this time.
• Are there any required elements for data entry on each patient?
  Yes, to use the Registry and for the USCLC to continue to pay for the platform costs, the members must enter the required elements on all patients who are enrolled in the Registry. The required elements are those necessary to accomplish the USCLC’s goals and to allow it to compete for national funding. There are many more optional data points to enter that we hope sites will want to include to enhance our knowledge of cutaneous lymphomas.
• Is there a related biorepository for patients whose clinical data is in the Registry?
  Yes, there is a virtual biorepository for those sites who have IRB approval for an institutional biorepository protocol and consent form. Patients enrolled in the Registry at these sites will have given approval to collect and store tissue and/or blood at their site. The USCLC does not own or determine how a site may use this tissue/blood but it has the potential to create, support or initiate translational research related to patients entered into the Registry.
• May USCLC members directly transfer their site’s data to other research studies?
  Yes, but all data entered into the Registry may not be transferred without approval of the study by the USCLC Registry Committee. Once approved by the USCLC, the site must obtain IRB approval at their site for the new research protocol and informed consent form, and the site to which the data are being transferred must sign a Data Use Agreement with the USCLC.
• If a site wishes to participate in the PROCLIPI study, does it need to enter data into the PROCLIPI site and the USCLC Registry separately?
  No, the USCLC has been working with Stanford University, which maintains the platform for the PROCLIPI study, to enable transfer of data from the USCLC Registry to Stanford for those sites who have independently also obtained regulatory approval for the PROCLIPI study. The USCLC has agreed to pay for the mapping of this data to Stanford specifically for the advanced mycosis fungoides and Sézary syndrome patients which are those exclusively studied in the PROCLIPI study. The USCLC has the capability of collecting data directly on all types of cutaneous T and B cell lymphoma and would hope to enable international physicians to use our platform directly for other collaborative projects.
• How do patients participate in the Registry?
  Each site must first have a fully authorized consent form for each patient approved by the Registry central site before being given a study number for that patient. Physicians would then give that patient information about signing up at a patient portal either on the USCLC or the Cutaneous Lymphoma Foundation website. Answers Ahead would periodically put forms for patients to fill out on the patient portal and notify patients of this. Some of the resulting data will be directly communicated to the physician entering clinical data on this patient, some would be given to the patient and some will be kept separate for purposes of research analysis.
• Are USCLC Registry participants able to enter photographs or photomicrographs of biopsy slides into the Registry?
  Yes, but there is an additional fee to the user for this. Please contact Answers Ahead for further information.
• Can data be uploaded directly from my EMR into the Registry?
  Not at the current time but this is a goal of Answers Ahead for first quarter 2017.
• Can I enter data into my EMR from the Registry?
  Yes, you can copy and paste from the Registry to your EMR. We have designated standard information that is collected at each follow-up visit to be collated on one page that can be easily copied and pasted into your clinic note. You may also create your own profile of data that you wish to be able to copy and paste into your clinical note.
• How do I get started?
  
  • The first thing to do is to ensure that your USCLC membership is current. Please contact Christine Lenihan at christine.Lenihan@tnmed.org if you have any doubts about whether your dues have been paid for the current year or go to USCLC.org Members portal at this link.
  • Then please go the Registry page on the USCLC website (USCLC.org). Once there, you can download the USCLC Site Agreement. This should be signed by your site's contracts designee and emailed to Dr. Elise Olsen at mailto:elise.olsen@duke.edu. If the contract person at your site has any issues with the Site Agreement, please direct them to Dr. Elise Olsen at elise.olsen@duke.edu.
  • You will also need to have IRB approval for the central protocol and informed consent form (ICF) -- these are also provided for download on the Members side of the USCLC registry website. Knowing that each site will need to make necessary amendments to the ICF to fulfill their site's requirements, please send any proposed changes first to Dr. Elise Olsen at elise.olsen@duke.edu before submitting to your IRB in order to insure the forms remain consistent with the approved centrally approved forms.
  • Once all has been done, you will be given access to the Answers Ahead Registry site with its portal on the Members side of the USCLC registry website at USCLC.org.