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

Conditions

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

  • France
    • Rhône Alpes
      • Pierre Bénite, Rhône Alpes, France, 69126
        • Centre Hospitalier Lyon Sud

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

Hospices Civils de Lyon

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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