Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant
NCT ID: NCT01077440
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
24 participants
OBSERVATIONAL
2010-02-28
2014-12-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Men - age 18+
DNA analysis
DNA analysis will be performed on samples collected.
polymerase chain reaction
A polymerase chain reaction (PCR) assessment will be done on the samples collected.
flow cytometry
Flow cytometry will be done on the samples collected.
laboratory biomarker analysis
Laboratory biomarker analysis will be performed on the samples collected.
Interventions
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DNA analysis
DNA analysis will be performed on samples collected.
polymerase chain reaction
A polymerase chain reaction (PCR) assessment will be done on the samples collected.
flow cytometry
Flow cytometry will be done on the samples collected.
laboratory biomarker analysis
Laboratory biomarker analysis will be performed on the samples collected.
Eligibility Criteria
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Inclusion Criteria
* 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:
* Able to consent and willing to provide a semen sample
* Survivors who present for long-term follow-up appointments in the adult and pediatric stem cell transplant clinic at Vanderbilt University Medical Center
* No known history of infertility or azospermia
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No history of testicular irradiation ≥ 200 cGy
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt University
OTHER
Responsible Party
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Haydar Frangoul
Professor of Pediatrics
Principal Investigators
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Haydar A. Frangoul, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-PED-0995
Identifier Type: -
Identifier Source: secondary_id
CDR0000666593
Identifier Type: -
Identifier Source: org_study_id