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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077440
Recruitment Status : Terminated (PI leaving institution)
First Posted : March 1, 2010
Last Update Posted : December 10, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Haydar Frangoul, Vanderbilt University

Study Description
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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.


Condition or disease Intervention/treatment
Cancer Survivor Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Testicular Germ Cell Tumor Genetic: DNA analysis Genetic: polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis

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 Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Donor-Derived DNA in Semen Samples Among Recipients of Allogeneic Hematopoietic Stem-Cell Transplants
Study Start Date : February 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Lymphosarcoma Mantle Cell Lymphoma Myelodysplastic Syndromes Primary Myelofibrosis Chronic Myeloproliferative Disorders Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Lymphocytic Leukemia B-cell Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Cutaneous T-cell Lymphoma Follicular Lymphoma Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Neuroblastoma Diffuse Large B-Cell Lymphoma Mycosis Fungoides Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Plasmacytoma Myelodysplastic/myeloproliferative Disease Burkitt Lymphoma Chronic Neutrophilic Leukemia Neuroepithelioma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Men - age 18+ Genetic: DNA analysis
DNA analysis will be performed on samples collected.

Genetic: 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.

Other: laboratory biomarker analysis
Laboratory biomarker analysis will be performed on the samples collected.


Outcome Measures
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Primary Outcome Measures :
  1. Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation [ Time Frame: end of study ]

Biospecimen Retention:   Samples With DNA

Your sample will only be used for research at Vanderbilt University and will not be sold. Health insurance companies and group health plans may not request your genetic information that comes from this research. As part of this study, we ask that the data from the semen analysis can be put into a databank at Vanderbilt and kept with data from other people in the study. Your data will be given a special code and will not identify you directly. We ask you to select yes or no to allow/disallow us to:

  • Use your semen sample for gene research.
  • Store/share your semen sample for future gene research in hematopoietic stem cell transplantation.
  • Store/share your semen sample for future gene research for other health problems (such as cancer, heart disease, etc).

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males over the age of 18 who have a history of allogeneic stem cell transplant >365 days ago with history of full donor engraftment, whose disease is in remission,
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077440


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Haydar A. Frangoul, MD Vanderbilt-Ingram Cancer Center
More Information
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Responsible Party: Haydar Frangoul, Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01077440    
Other Study ID Numbers: CDR0000666593
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-PED-0995
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014
Keywords provided by Haydar Frangoul, Vanderbilt University:
cancer survivor
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
 stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive