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

Lymphoma Clinical Trial

Official title:

Detection of Donor-Derived DNA in Semen Samples Among Recipients of Allogeneic Hematopoietic Stem-Cell Transplants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01077440
• Other study ID #: CDR0000666593
• Secondary ID: P30CA068485VU-VI
• Status: Terminated
• Phase: Phase 1
• First received: February 26, 2010
• Last updated: December 8, 2014
• Start date: February 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer Survivor
• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Plasma Cell
• Neuroblastoma
• Plasmacytoma
• Preleukemia
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Genetic:
• 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.

Other:
• flow cytometry
Flow cytometry will be done on the samples collected.
• laboratory biomarker analysis
Laboratory biomarker analysis will be performed on the samples collected.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation		end of study	No