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Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant

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Vanderbilt University

Status

Terminated

Conditions

Multiple Myeloma and Plasma Cell Neoplasm
Neuroblastoma
Chronic Myeloproliferative Disorders
Cancer Survivor
Lymphoma
Leukemia
Myelodysplastic Syndromes
Testicular Germ Cell Tumor
Myelodysplastic/Myeloproliferative Neoplasms

Treatments

Genetic: polymerase chain reaction
Other: flow cytometry
Genetic: DNA analysis
Other: laboratory biomarker analysis

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01077440
P30CA068485 (U.S. NIH Grant/Contract)
CDR0000666593
VU-VICC-PED-0995

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

  • 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

Trial design

24 participants in 1 patient group

Men - age 18+
Treatment:
Other: flow cytometry
Other: laboratory biomarker analysis
Genetic: DNA analysis
Genetic: polymerase chain reaction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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