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

Terminated

• Conditions: Cancer Survivor; Myelodysplastic/Myeloproliferative Neoplasms; Lymphoma; Leukemia; Myelodysplastic Syndromes; Multiple Myeloma and Plasma Cell Neoplasm; Neuroblastoma; Chronic Myeloproliferative Disorders; Testicular Germ Cell Tumor
• Interventions: Genetic: DNA analysis; Genetic: polymerase chain reaction; Other: flow cytometry; Other: laboratory biomarker analysis

• Registration Number: NCT01077440
• Lead Sponsor: Vanderbilt University

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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men - age 18+	polymerase chain reaction	-
Men - age 18+	flow cytometry	-
Men - age 18+	DNA analysis	-
Men - age 18+	laboratory biomarker analysis	-

Primary Outcome Measures

Name	Time	Method
Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation	end of study

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States