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TerminatedNCT01077440Updated Dec 10, 2014

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

An observational study in Cancer Survivor, Chronic Myeloproliferative Disorders and Leukemia, sponsored by Vanderbilt University. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-10.

Sponsored by Vanderbilt University · Observational

Why this study was terminated
PI leaving institution
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Cancer Survivor
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Neuroblastoma
  • Testicular Germ Cell Tumor

Keywords

  • 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
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • atypical chronic myeloid leukemia, BCR-ABL negative
  • blastic phase chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • chronic eosinophilic leukemia
  • primary myelofibrosis
  • chronic neutrophilic leukemia
  • de novo myelodysplastic syndromes
  • disseminated neuroblastoma
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • previously treated myelodysplastic syndromes
  • recurrent neuroblastoma
  • recurrent malignant testicular germ cell tumor
  • secondary myelodysplastic syndromes
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage III malignant testicular germ cell tumor
  • refractory multiple myeloma
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 24 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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,

Eligibility 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
24 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Men - age 18+

    Genetic: DNA analysis · Genetic: polymerase chain reaction · Other: flow cytometry · Other: laboratory biomarker analysis

Interventions

  • GeneticDNA analysis

    DNA analysis will be performed on samples collected.

  • Geneticpolymerase chain reaction

    A polymerase chain reaction (PCR) assessment will be done on the samples collected.

  • Otherflow cytometry

    Flow cytometry will be done on the samples collected.

  • Otherlaboratory biomarker analysis

    Laboratory biomarker analysis will be performed on the samples collected.

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What researchers measure

Primary outcomes

  1. Presence of donor-derived DNA in semen samples of male survivors of allogeneic hematopoietic stem cell transplantation

    Time frame: end of study

07

Study locations

1 site
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01077440
Lead sponsor
Vanderbilt University
Collaborators
National Cancer Institute (NCI)
Responsible party
Haydar Frangoul (Professor of Pediatrics, Vanderbilt University) — Principal investigator
First posted
Mar 1, 2010
Start date
Feb 2010
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 10, 2014

Study contacts

Haydar A. Frangoul, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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