Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mediastinal Grey Zone Lymphoma From the LYSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037177
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date November 4, 2016
First Posted Date January 31, 2017
Last Update Posted Date January 31, 2017
Study Start Date January 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2017)
EFS in the global population of GZL [ Time Frame: EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months ]
Event-free survival (EFS) was calculated from the date of diagnosis to the date of progression, a change of therapy that was not initially scheduled (radiotherapy, high-dose therapy with autologous stem cell transplantation and other unplanned treatments) or death from any cause.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mediastinal Grey Zone Lymphoma From the LYSA
Official Title Mediastinal Grey Zone Lymphoma: Clinico-pathological Characteristics and Outcomes of 99 Patients From the LYSA
Brief Summary Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists.
Sampling Method Non-Probability Sample
Study Population We retrospectively identified cases treated in French, Belgium and Portuguese LYSA centers suspected to be MGZL using local pathological records, records from LYSA centers and the LYMPHOPATH network, which aims to review all newly diagnosed lymphoma cases in France (14). All the FFPE blocks and immunohistochemistry (IHC) slides (obtained prior any treatment) were centralized in the LYSA-Pathology (LYSA-P) department located in Henri Mondor hospital in Paris to perform a central review by a panel of hematopathologists. Two hundred and four cases were reviewed by the panel of LYSA hematopathologists.
Condition Mediastinal Grey Zone Lymphoma
Intervention Not Provided
Study Groups/Cohorts
  • CHL like GZL
    Classical Hodgkin Lymphoma like Grey Zone Lymphoma (morphology of CHL and phenotype of PMBCL)
  • PMBCL like GZL
    Primary Mediastinal B Cell Lymphoma like Grey Zone Lymphoma(morphology of PMBCL and phenotype of CHL)
  • Composite
    with a morphology of CHL on the one side and of PMBCL on the other side of the same diagnosis biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 27, 2017)
99
Original Actual Enrollment Same as current
Actual Study Completion Date June 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • cases with an intermediate morphology and phenotype between CHL and PMBCL were included after central pathological review

Exclusion Criteria:

  • Cases of CHL with partial CD20 expression or low expression in tumoral cells were excluded and considered as CD20-positive CHL
  • Exclusion of sequential form patients (with a diagnostic biopsy of PMBCL and a relapse biopsy of CHL or vise-versa) as they represent a biases for statistical analysis.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03037177
Other Study ID Numbers 69HCL16_0721
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date October 2016