Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 241
- 试验地点
- 21
- 主要终点
- Rate of Overall Survival
研究概览
简要总结
This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD.
The aim of the study is to analyze the clinical features and survival of patients who received a PTLD diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by PTLD, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments.
详细描述
This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. Retrospective data will be collected for all cases of PTLD diagnosed during a 10 years period since 1st January 2011 to 31th December 2021.
The following clinical characteristics of the patient at the time of PTLD diagnosis and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological diagnosis of PTLD obtained from a biopsy sample (availability of stocked biopsy sample is requested but not mandatory);
- •age over 18 years at time of diagnosis of PTLD;
- •previously subjected to allogeneic transplantation (both SOT and HSCT);
- •diagnosis of PTLD obtained in 10 years' time frame (from 01/01/2011 to 31/12/2021);
- •free and voluntary written informed consent (included unreachable subjects according to Art. 36 UE Regulation 2016/679 and to the current Italian Privacy Regulation).
排除标准
- •Patients not meeting the above-mentioned inclusion criteria.
结局指标
主要结局
Rate of Overall Survival
时间窗: from diagnosis of PTLD to patient's death / last FUP - up to 18 months.
survival after PTLD incidence rating
clinical and epidemiological features
时间窗: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
analyze the clinical and epidemiological features (e.g. positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained) of PTLD patients
次要结局
- Rate of Progression Free Survival(from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.)
- Overall Survival stratified by prognostic factors(from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.)
- Overall Response Rate(from treatment of PTLD to patient's death / last FUP - up to 18 months.)
- Progression Free Survival stratified by prognostic factors(from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.)
- Complete Response Rate to first and subsequent treatments(from treatment of PTLD to patient's death / last FUP - up to 18 months.)