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

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