Study Stopped
PI leaving institution
Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant
Detection of Donor-Derived DNA in Semen Samples Among Recipients of Allogeneic Hematopoietic Stem-Cell Transplants
3 other identifiers
observational
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 10, 2014
December 1, 2014
4.8 years
February 26, 2010
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation
end of study
Study Arms (1)
Men - age 18+
Interventions
A polymerase chain reaction (PCR) assessment will be done on the samples collected.
Laboratory biomarker analysis will be performed on the samples collected.
Eligibility Criteria
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,
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Vanderbilt Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Biospecimen
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).
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haydar A. Frangoul, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 26, 2010
First Posted
March 1, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 10, 2014
Record last verified: 2014-12