Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant
This study is currently recruiting participants.
Verified August 2011 by Vanderbilt University
Sponsor:
Vanderbilt University
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01077440
First received: February 26, 2010
Last updated: August 4, 2011
Last verified: August 2011
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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:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
neuroblastoma
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
Drug Information available for:
Deoxyribonucleic acid
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
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 A Frangoul, MD, Vanderbilt-Ingram Cancer Center |
| 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: | August 4, 2011 |
| 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 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 Neuroectodermal Tumors, Primitive |
ClinicalTrials.gov processed this record on May 22, 2013