Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant
Study Details
Study Description
Brief Summary
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 | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
- 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation [end of study]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Disease in remission
-
More than 365 days since prior allogeneic hematopoietic stem cell transplantation with history of full donor engraftment
-
Stable complete donor chimerism
PATIENT CHARACTERISTICS:
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Able to consent and willing to provide a semen sample
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Survivors who present for long-term follow-up appointments in the adult and pediatric stem cell transplant clinic at Vanderbilt University Medical Center
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No known history of infertility or azospermia
PRIOR CONCURRENT THERAPY:
-
See Disease Characteristics
-
No history of testicular irradiation ≥ 200 cGy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
Sponsors and Collaborators
- Vanderbilt University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Haydar A. Frangoul, MD, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000666593
- P30CA068485
- VU-VICC-PED-0995