This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as Myelodysplastic (MDS)/myeloproliferative (MPN) diseases and question 480 as Juvenile Myelomonocytic Leukemia (JMML/JCML). The Juvenile Myelomonocytic Leukemia Post-HCT Data (Form 2115) must be completed in conjunction with each Post-HCT follow-up form (Forms 2100, 2200, 2300) completed. The form is designed to capture specific data occurring within the timeframe of each reporting period (i.e., between day 0 and day 100 for Form 2100, between day 100 and the six-month date of contact for Form 2200, between the date of contact for the six-month follow up and the date of contact for the one-year follow up for Form 2200, etc.).
For recipients who had JMML that transformed to AML prior to transplant, it is only necessary to complete Form 2110 (Acute Myelogenous Leukemia Post-HCT Data). Although form 2015 (Juvenile Myelomonocytic Leukemia Pre-HCT Data) is required to obtain JMML data pre-HCT, Form 2115 (Juvenile Myelomonocytic Leukemia Post-HCT Data) is not required for these recipients.
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|3/19/18||Comprehensive Disease Specific Manuals||Add|| Added the following instruction for applicable post-infusion disease-specific forms where current disease status is asked (2110, 2111, 2112, 2113, 2114, 2115, 2116, 2118, 2119).
The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.
|2/24/17||Comprehensive Disease-Specific Manuals||Modify||Updated explanations of triggers for disease inserts to refer to the primary disease reported on the Pre-TED Disease Classification Form (Form 2402) instead of the Pre-TED Form (Form 2400)|
Need more help with this?
Don’t hesitate to contact us here.