Breast CancerNCT00900406
Collecting and Storing Tissue and DNA Samples From Patients Undergoing a Donor Stem Cell Transplant
An observational study of Breast Cancer and Chronic Myeloproliferative Disorders, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients undergoing a donor stem cell transplant to test in the laboratory may help the study of graft-versus-host disease in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor
- What is being tested?
- gene expression analysis, microarray analysis and polymorphism analysis
- Type of treatment
- Surgery or procedure
- How many people
- 190 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who have received a stem cell transplant and are being treated for graft versus host disease or are at risk of graft versus host disease.
DISEASE CHARACTERISTICS:
- Approved for allogeneic stem cell transplantation
- Sample of the stem cells from donor must meet 1 of the following criteria:
- Total peripheral blood stem cell dose > 5 X10^6 CD34+ cells/kg
- Marrow cell dose > 3 X 10^8 nucleated cells/kg
PATIENT CHARACTERISTICS:
- Platelet count > 50,000/mm³ (for patients undergoing endoscopic biopsies)
- INR < 1.5 (for patients undergoing endoscopic biopsies)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Tissue Bank for Studies Related to Graft-Versus-Host Disease (GVHD)
RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients undergoing a donor stem cell transplant to test in the laboratory may help the study of graft-versus-host disease in the future.
PURPOSE: This research study is collecting and storing tissue and DNA samples from patients undergoing a donor stem cell transplant.
Read the detailed description
OBJECTIVES:
- To establish a DNA bank from donor and recipient (prior to transplant) peripheral blood for SNP studies.
- To establish a tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples.
- To establish a tissue bank for proteomic studies using donor and recipient blood and urine samples.
- To establish a tissue bank for various studies using biopsy specimens.
- To establish a tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product.
OUTLINE: Peripheral blood samples are collected from donors prior to stem cell mobilization and from patients prior to starting preparative regimen. Samples are studied by single nucleotide polymorphism (SNP) analysis, SNP array, proteomic analysis, gene expression, and other immunological laboratory methods. Blood, urine, and tissue samples are preserved for future studies. Extra skin biopsies and gastrointestinal biopsies are performed at diagnosis of graft-vs-host disease and preserved in a tissue bank for flow cytometric studies.
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Graft Versus Host Disease, Leukemia, Lymphoma
- Being tested
- gene expression analysis, microarray analysis, polymorphism analysis, proteomic profiling, flow cytometry
- Medical subject headings
- Breast Neoplasms, Myeloproliferative Disorders, Gestational Trophoblastic Disease, Graft vs Host Disease, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
blood collection
microarray analysisGenetic
Blood collection
polymorphism analysisGenetic
Blood collection
proteomic profilingGenetic
Blood collection
flow cytometryOther
Blood collection
immunologic techniqueOther
Blood collection
laboratory biomarker analysisOther
Blood collection
biopsyProcedure or surgery
Blood collection
| Study group | Role | What they receive |
|---|---|---|
| Recipients of stem cells with graft versus host disease | Not described Receives: Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: polymorphism analysis; Genetic: proteomic profiling; Other: flow cytometry; Other: immunologic technique; Other: laboratory biomarker analysis; Procedure: biopsy | |
| Recipients of stem cells at risk of graft versus host disease | Not described Receives: Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: polymorphism analysis; Genetic: proteomic profiling; Other: flow cytometry; Other: immunologic technique; Other: laboratory biomarker analysis; Procedure: biopsy | |
| Donator of stem cells | Not described Receives: Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: polymorphism analysis; Genetic: proteomic profiling; Other: flow cytometry; Other: immunologic technique; Other: laboratory biomarker analysis; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies
Measured: Completion of transplant
Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples
Measured: End of treatment
Tissue bank for proteomic studies using donor and recipient blood and urine samples
Measured: End of treatment
Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product
Measured: End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Madan Jagasia, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900406
- Sponsor's protocol ID
- VICC BMT 0664
- Other IDs
- P30CA068485, VU-VICC-BMT-0664, VU-VICC-IRB-061215
- Status last verified
- Nov 2012
- First submitted
- 9 May 2009
- Last updated
- 6 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Bank for Studies Related to Graft-Versus-Host Disease (GVHD)
- ClinicalTrials.gov ID
- NCT00900406
- Acronym / sponsor ID
- VICC BMT 0664
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Graft Versus Host Disease, Leukemia, Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients undergoing a donor stem cell transplant to test in the laboratory may help the study of graft-versus-host disease in the future.
PURPOSE: This research study is collecting and storing tissue and DNA samples from patients undergoing a donor stem cell transplant.
Detailed description
OBJECTIVES:
- To establish a DNA bank from donor and recipient (prior to transplant) peripheral blood for SNP studies.
- To establish a tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples.
- To establish a tissue bank for proteomic studies using donor and recipient blood and urine samples.
- To establish a tissue bank for various studies using biopsy specimens.
- To establish a tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product.
OUTLINE: Peripheral blood samples are collected from donors prior to stem cell mobilization and from patients prior to starting preparative regimen. Samples are studied by single nucleotide polymorphism (SNP) analysis, SNP array, proteomic analysis, gene expression, and other immunological laboratory methods. Blood, urine, and tissue samples are preserved for future studies. Extra skin biopsies and gastrointestinal biopsies are performed at diagnosis of graft-vs-host disease and preserved in a tissue bank for flow cytometric studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recipients of stem cells with graft versus host disease | – | Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: polymorphism analysis, Genetic: proteomic profiling, Other: flow cytometry, Other: immunologic technique, Other: laboratory biomarker analysis, Procedure: biopsy |
| Recipients of stem cells at risk of graft versus host disease | – | Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: polymorphism analysis, Genetic: proteomic profiling, Other: flow cytometry, Other: immunologic technique, Other: laboratory biomarker analysis, Procedure: biopsy |
| Donator of stem cells | – | Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: polymorphism analysis, Genetic: proteomic profiling, Other: flow cytometry, Other: immunologic technique, Other: laboratory biomarker analysis, Procedure: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have received a stem cell transplant and are being treated for graft versus host disease or are at risk of graft versus host disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysisblood collection | Genetic | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
| microarray analysisBlood collection | Genetic | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
| polymorphism analysisBlood collection | Genetic | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
| proteomic profilingBlood collection | Genetic | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
| flow cytometryBlood collection | Other | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
| immunologic techniqueBlood collection | Other | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
| laboratory biomarker analysisBlood collection | Other | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
| biopsyBlood collection | Procedure or surgery | Donator of stem cells, Recipients of stem cells at risk of graft versus host disease, Recipients of stem cells with graft versus host disease |
Primary outcome
DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies
Time frame: Completion of transplant
Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples
Time frame: End of treatment
Tissue bank for proteomic studies using donor and recipient blood and urine samples
Time frame: End of treatment
Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product
Time frame: End of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madan Jagasia, MD study chair
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chronic Myeloproliferative Disorders, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies (time frame: Completion of transplant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.