- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984215
aCGH Impacts Survival in Plasma Cell PTLD
December 2, 2016 updated by: Hospices Civils de Lyon
Array-CGH in Plasma Cell Post-transplantation Lymphoproliferative Disorders
Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD.
To date, there is no exhaustive published cytogenetic data on PC-PTLD.
The investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhône Alpes
-
Pierre Bénite, Rhône Alpes, France, 69126
- Centre Hospitalier Lyon Sud
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We conducted a retrospective analysis between 1990 and 2012 of all consecutive cases of PCM and PLL-PTLD collected in the Centre Hospitalier Lyon Sud (CHLS, 6 cases) and in Necker - Enfants Malades Hospital in Paris (4 cases).
There were 4 females and 6 males.
Among the 8 adults, 6 had received a kidney transplant, 1 a heart transplant and one a lung transplant.
Among the 2 children, one had received a heart transplant and one an allogeneic stem cell transplantation with a matched unrelated donor.
Immunosuppressive regimens were heterogeneous.
Description
Inclusion Criteria:
- WHO classification 2008 as monomorphic PCM (plasma cell myeloma) or PLL (plasmacytoma like lesion) / PTLD (post transplantation lymphoproliferative disorders).
Exclusion Criteria:
- Other than PCM or PLL PTLD at diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Genome wide array-based comparative genomic hybridization (aCGH)
Time Frame: At diagnosis of PTLD, Day 0.
|
At diagnosis of PTLD, Day 0.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival according to aCGH complexity
Time Frame: Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months.
|
Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1990
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (Estimate)
December 6, 2016
Study Record Updates
Last Update Posted (Estimate)
December 6, 2016
Last Update Submitted That Met QC Criteria
December 2, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0720
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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