Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInternational Extranodal Lymphoma Study Group (IELSG)
About this trial
Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced overall survival. At the present time, there are no recommended treatments intended specifically to t-SMZL and little is known about t-SMZL genetic complexity. The aim of this study is to provide information that will help clinicians to better understand the complexity of the disease. The information gained from this study will also lead to more specific and effective treatment for patients with t-SMZL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older, regardless of the gender;
Diagnosis of HT of SMZL (both at baseline, co-occurring with diagnosis of SMZL, or during the natural history of the disease);
Availability of diagnostic tumor material (either frozen or FFPE) from spleen, lymph node, extra nodal site, peripheral blood or bone marrow collected at the time of histological transformation. Tumor material (either frozen or FFPE), from spleen, peripheral blood or bone marrow, collected at the time of SMZL diagnosis will be also collected, if available;
Availability of the baseline and follow-up annotations.
Disqualifiers
None
Trial population
Adult patients with transformed SMZL
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence of mutations, copy number abnormalities and structural variants at SMZL diagnosis and at HT
Time frame
30 months: from the end of samples collection to the end of study analysis2
Quantification and qualification of lesions acquired at the time of HT.
Time frame
30 months: from the end of samples collection to the end of study analysis3
Prevalence of clonal relationship between SMZL and HT
Time frame
30 months: from the end of samples collection to the end of study analysisSecondary outcomes
1
Prevalence of HT molecular subtypes defined by genetic lesions
Time frame
30 months: from the end of samples collection to the end of study analysis2
Prevalence of Histological Transformation (HT) molecular subtypes defined by gene expression
Time frame
30 months: from the end of samples collection to the end of study analysis3
Prevalence of HT molecular subtypes defined by genetic methylation profile
Time frame
30 months: from the end of samples collection to the end of study analysis4
Prevalence of molecular features in relation with clinical, laboratory and radiological/Positron Emission Tomography (PET) features at SMZL diagnosis and at HT
Time frame
30 months: from the end of samples collection to the end of study analysisSponsors and contacts
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Source ClinicalTrials.gov