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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Haydar Frangoul, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01077440
First received: February 26, 2010
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
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
Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Lymphosarcoma Lymphoma, Small Cleaved-cell, Diffuse Acute Lymphoblastic Leukemia Testicular Cancer Multiple Myeloma Chronic Myeloproliferative Disorders Hodgkin Lymphoma Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Neuroblastoma Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Lymphoblastic Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Mantle Cell Lymphoma Cutaneous T-cell Lymphoma Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Anaplastic Plasmacytoma Neuroepithelioma
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation [ Time Frame: end of study ] [ Designated as safety issue: No ]

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).

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077440

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Principal Investigator: Haydar A Frangoul, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Haydar A. Frangoul, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Haydar Frangoul, Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01077440     History of Changes
Other Study ID Numbers: CDR0000666593, P30CA068485, VU-VICC-PED-0995
Study First Received: February 26, 2010
Last Updated: July 19, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
myelodysplastic/myeloproliferative neoplasm, unclassifiable
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

Additional relevant MeSH terms:
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Neuroblastoma
Lymphoma, Large-Cell, Immunoblastic
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neuroectodermal Tumors, Primitive, Peripheral

ClinicalTrials.gov processed this record on August 28, 2014