Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01077440|
Recruitment Status : Terminated (PI leaving institution)
First Posted : March 1, 2010
Last Update Posted : December 10, 2014
RATIONALE: Studying samples of semen from cancer survivors in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This phase I research study is looking at the presence of donor-derived DNA in semen samples form cancer survivors who underwent donor stem cell transplant.
|Condition or disease||Intervention/treatment|
|Cancer Survivor Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Testicular Germ Cell Tumor||Genetic: DNA analysis Genetic: polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis|
- To examine semen samples from male survivors of allogeneic hematopoietic stem cell transplantation for the presence of donor-derived DNA.
OUTLINE: Semen samples are collected and assessed by flow cytometry and PCR. DNA samples are compared to previously analyzed DNA extracted from survivor and donor. Samples are also analyzed for sperm concentration, motility, morphology, and viability.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Detection of Donor-Derived DNA in Semen Samples Among Recipients of Allogeneic Hematopoietic Stem-Cell Transplants|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|Men - age 18+||
Genetic: DNA analysis
DNA analysis will be performed on samples collected.
Genetic: polymerase chain reaction
A polymerase chain reaction (PCR) assessment will be done on the samples collected.
Other: flow cytometry
Flow cytometry will be done on the samples collected.
Other: laboratory biomarker analysis
Laboratory biomarker analysis will be performed on the samples collected.
- Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation [ Time Frame: end of study ]
Biospecimen Retention: Samples With DNA
Your sample will only be used for research at Vanderbilt University and will not be sold. Health insurance companies and group health plans may not request your genetic information that comes from this research. As part of this study, we ask that the data from the semen analysis can be put into a databank at Vanderbilt and kept with data from other people in the study. Your data will be given a special code and will not identify you directly. We ask you to select yes or no to allow/disallow us to:
- Use your semen sample for gene research.
- Store/share your semen sample for future gene research in hematopoietic stem cell transplantation.
- Store/share your semen sample for future gene research for other health problems (such as cancer, heart disease, etc).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077440
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Haydar A. Frangoul, MD||Vanderbilt-Ingram Cancer Center|