Participation in Registry, Research Database, and Research Sample Repository for Patients Undergoing Hematopoietic Cell Transplantation or Cellular Therapies

Study ID
STU 112010-001

Cancer Related

Healthy Volunteers

Study Sites

  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital

Mirjana Tadic-Ovcina

Principal Investigator
Robert Collins, M.D.


Concise Summary of Project: This Research involves patients who will undergo a Hematopoeitic Stem Cell transplant. The patients will have already signed consent forms outlining the nature of this transplant and its potential risks and benefits. This study is used to allow for collection of data for the Research Database and allow for blood samples to be collected that will be sent to the Sample Repository and a translational laboratory that will use it for research.

Study Procedures: Recipient data are collected from pre-existing data within the recipient's medical record chart at the transplant center. Data extracted will be: demographic data such as race, ethnicity, gender, age, median household income, HLa typing data, pre-transplant disease-specific data such as blood counts, disease status, cytogenetics, co-existing disease at the time of transplant, functional status, organ function prior to transplant, history of infection exposure prior to transplant and conditioning regimen, HSC product manipulation, engraftment x neutrophil and platelet counts, acute and chronic Graft vs. Host Disease information, chimerism, organ function, new malignancy, disease status post transplant, functional status post transplant, ability to return to work or school post transplant, second transplant and donor leukocyte infusion information (if applicable). also, in the event of death, cause of death information will be collected.

Donor data is collected at the time a donor joins the Registry, when a donor is requested for confirmatory typing to determine if he/she is a match with a potential recipient, during the work-up phase to determine eligibility to donate HSC, and post-collection of the HSC product. Donor data extracted will be: HLa typing, race, gender, date of birth, infectious disease markers for hepatitis B and C, syphilis, HiV, CMV, HTLV i/ii weight, aBo, Rh (Du) type, allogeneic blood transfusion, number of pregnancies, serum pregnancy test (PBSC donors only), screening for hemoglobin S (sickle hemoglobin), number and type of cells, sterility, other factors related to transplant, adverse events related to HSC collection, ability to return to work, school and leisure activities.

We do not participate in the other Cellular Therapies or Marrow Toxic injuries. as described in Section 2.2 of the Protocol, marrow toxic injury is the instance where transplant might be urgent, and recipient unable to consent and we are not one of the participating centers. all of our potential transplant recipients are consented well ahead of the admission for transplant. no data is submitted and there are no study procedures being done before consenting of potential transplant recipient at our center.

Participant Eligibility

Subjects will be:
-Patients (and their donors if applicable) of investigators here at UTSW who are considered candidates for Hematopoietic Stem Cell (HSC) Transplantation.
-Ages of 18 - 75