National Subjective Global Assessment Validation Project

Principal Investigator: Alison L. Steiber, MS, RD, Doctoral Candidate

Collaborators: Barbara Ives, RD and Cheryl Hathaway, RD

Sponsor: National Kidney Foundation Council on Renal Nutrition

Objective: Subjective Global Assessment (SGA) is an assessment tool utilizing clinical & physical data to classify nutritional status. The purpose of this study is to form a Collaborative National Research Group through the Council on Renal Nutrition (CRN) to examine the reliability & validity of SGA in a nationally representative hemodialysis population. It will be a prospective, observational study involving patients >18 years of age (both men & women) with Chronic Kidney Disease, who are receiving maintenance hemodialysis treatment. Renal dieticians throughout the CRN network will be recruited to collect the following data: SGA scores, serum laboratory markers of nutritional status (including serum albumin, pre & post blood urea nitrogen), and inflammation (including serum C-reactive protein), anthropometrics and dietary data, mortality, and hospitalization information. The risks involved in this study are no greater than those involved in route dialysis care of the patients. The results of this study will be used to identify the reliability and validity of SGA, best practices in SGA technique, and establish the appropriate utilization and interpretation of SGA in nutritional assessment of hemodialysis patients.

SWOG S0106: A Phase III study of the addition of Gemtuzumab Ozogamicin (Mylotarg) induction therapy versus standard induction with Daunomycin and Cytosine Arabinoside, followed by consolidation and subsequent randomization to post-consolidation therapy for patients under age 56 with previously untreated De Novo acute myeloid leukemia (AML).

Ancillary Studies:

• S9910 – Leukemia Centralized Reference Laboratories and Tissue Repositories – Consent to Perform Cellular and Molecular Studies in Leukemia Patients
• S9007 – Cytogenetic Studies in Leukemia Patients

Principal Investigator: Robert J. Gottlieb, MD

Collaborators: Hematology/Oncology Physicians of Lancaster

Sponsor: Southwest Oncology Group

Objective: The purpose of this protocol is to compare the disease-free survival of patients under age 56 with previously untreated De Novo non-M3 AML who received Mylotarg as post-conduction therapy versus patients who receive no post-conduction therapy, also to compare the (CR) and the durability of the (CR) of induction chemotherapy with Mylotarg versus without it. This study will also look at the frequency and severity of the toxicities with the addition of Mylotarg.