FDG PET 评估边缘区淋巴瘤及其预后作用 (PIMENTO)
FDG PET 评估边缘区淋巴瘤及其预后作用：一项国际多中心回顾性分析
The general aim of the present study is to assess the role of PET for the staging and for the assessment of response and outcome prediction in Marginal Zone Lymphoma (MZL). This study will be conducted as a multicenter retrospective analysis of MZL for whom PET scan are available as DICOM file for central review.
The study is designed as a retrospective collection of patients with MZL enrolled in the prospective IELSG36 and IELSG38 trials sponsored by IELSG and in the observational NF10 study sponsored by Federazione Italiana Linfomi (FIL), with the possibility to add additional cases from participating institutions.
The study will be conducted on performed scans. No additional scan or procedure will be required for study purposes.
The study will be divided into two sections with different aims:
Part A will be conducted to understand the role of PET for the staging of MZL. PET scans will be analyzed and compared with data retrieved from CT scan and from other staging procedures, also including bone marrow biopsy, ultrasound, and laboratory exams. This part of the study will describe ability of PET to identify pathologic lesions and to contribute to staging definition or to stage migration.
Part B will be conducted to validate standardized criteria for response assessment in MZL including FDG-PET among procedures and to define the prognostic role of metabolic response in MZL. For this purpose the primary endpoint for this part of the study is defined as the progression free survival. Secondary endpoint will be Overall survival, and response rate defined with conventional procedures and rate of histological transformation.
研究概览
地位
条件
详细说明
A significant proportion of patients considered for this study will be retrieved from previous observational prospective clinical studies. Data on clinical presentation, treatment and follow-up will be obtained from the existing dataset of the previous protocols. For the additional cases identified from clinical practice data will be collected from patient chart. A unique study CRF will be prepared to collect all the required details.
Patients with histologically confirmed marginal zone lymphomas according to the current WHO classification are registered in the study. Moreover, patients characteristics (PS, systemic symptoms), Ann Arbor stage, laboratory parameters, serology for hepatitis C, B and human immunodeficiency virus, bone marrow aspirate and biopsy data, data on treatment start and end, chemotherapy details, final response defined according to Cheson 2014 and Matutes criteria, date of last follow-up ,occurrence of any event (relapse, progression, death) with date will be collected.
PET response will be initially coded according to local interpretation of scan report. All FDG-PET, will be then centralized to perform a blinded independent review of staging and response. Images will be centralized and examined by a panel of 3 nuclear medicine physicians that will independently review the scans. Each case will be evaluated by two reviewers. In case of discordant results a third reviewer will adjudicate the case.
Each patient enrolled in the study will be anonymized by assigning a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data.
Anonymized PET data will be uploaded into the DICOM system by the responsible person of the site.
Anonymized health-related data will be collected in the e-CRF. At each site, the responsible of the research or a delegated person will complete the e-CRF.
Only the Study Chair and the Sponsor will have access rights for the health-related data and will be responsible for protection of the data.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Bari、意大利、70124
- IRCCS Istituto Tumori "Giovanni Paolo II"
-
Naples、意大利、80131
- AOU Federico II
-
Reggio Emilia、意大利、42123
- AUSL IRCCS Reggio Emilia
-
-
AL
-
Alessandria、AL、意大利、15121
- ASO SS. Antonio e Biagio e C. Arrigo
-
-
BI
-
Ponderano、BI、意大利、13875
- Ospedale degli Infermi
-
-
CA
-
Cagliari、CA、意大利、09121
- Ospedale Oncologico Businco
-
-
CT
-
Catania、CT、意大利、95123
- "G. Rodolico", AOU Policlinico Vittorio Emanuele
-
-
MI
-
Milan、MI、意大利、20132
- Ospedale San Raffaele
-
Milan、MI、意大利、20122
- Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico
-
Milan、MI、意大利、20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
-
PA
-
Palermo、PA、意大利、90144
- AOU Policlinico "Paolo Giaccone"
-
-
PD
-
Padova、PD、意大利、35128
- I.R.C.C.S. Istituto Oncologico Veneto
-
-
PE
-
Pescara、PE、意大利、65124
- Ospedale Civile Spirito Santo Pescara
-
-
PN
-
Aviano、PN、意大利、33081
- IRCCS Centro di Riferimento Oncologico di Aviano
-
-
PV
-
Pavia、PV、意大利、27100
- Fondazione IRCCS Policlinico S. Matteo di Pavia
-
-
TO
-
Candiolo、TO、意大利、10060
- Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
-
Torino、TO、意大利、10126
- A.O.U. Città della Salute e della Scienza di Torino
-
-
TR
-
Terni、TR、意大利、05100
- A.O. Santa Maria di Terni
-
-
VA
-
Varese、VA、意大利、21100
- Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese
-
-
VR
-
Verona、VR、意大利、37134
- Policlinico GB Rossi
-
-
-
-
-
Dijon、法国、21000
- CHU de Dijon
-
Paris、法国
- Saint Louis Hospital
-
Toulouse、法国、31100
- IUCT Oncopole Toulouse
-
-
-
-
Canton Ticino
-
Bellinzona、Canton Ticino、瑞士、6500
- Istituto Oncologico della Svizzera Italiana
-
-
Canton of Geneva
-
Geneva、Canton of Geneva、瑞士、1205
- Hôpiteux Universitaires de Genève (HUG)
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with MZL enrolled in the prospective IELSG36 and IELSG38 trials and on the observational NF10, with the possibility to add additional cases from participating institutions
描述
Inclusion Criteria:
-
One of the following subtypes of Histology confirmed Indolent non-follicular B-cell lymphoma:
- Splenic MZL (bone marrow histology and/or splenic tissue);
- Extranodal MZL or MALT (tissue biopsy);
- Nodal MZL (lymph node biopsy).
-
Age over 18.
-
Availability of details on clinical presentation, treatment details and results, and on follow-up.
-
Execution of PET at diagnosis or/and at end of treatment or/and at relapse.
-
Execution of CT scan with iodine contrast medium at diagnosis and at assessment of response.
-
Patients with histologically confirmed marginal zone lymphomas according to the current WHO classification are registered in the study. Diagnosis based on tru-cut core-needle biopsies are permitted in the study.
-
Written informed consent.
Exclusion Criteria:
- Patients with a diagnosis of Non Hodgkin Lymphoma other than MZL.
- Scans images not available for whatever reason.
- Cases diagnosed on fine needle aspiration cytology only.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
|---|
|
Group A
Staging |
|
Group B
Criteria for response assessment |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between CT and PET
大体时间：At baseline
|
To correlate CT and PET results for stage definition |
At baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
无进展生存期 (PFS)
大体时间：从入组日期到首次记录的进展日期、或最后一次随访日期或因任何原因死亡的日期，以先到者为准，最长评估 10 年
|
从入组日期到首次记录的进展日期、或最后一次随访日期或因任何原因死亡的日期，以先到者为准，最长评估 10 年
|
|
|
Duration of Response (DoR)
大体时间：From date of first response to the date of relapse, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years
|
DoR is evaluated only for responding patients |
From date of first response to the date of relapse, or last follow up, or date of death from any cause, whichever came first, assessed up to a maximum of 10 years
|
合作者和调查者
调查人员
- 学习椅：Catherine Thieblemont, MD、Saint-Louis Hospital, Paris, France
- 学习椅：Stefano Luminari, MD、AUSL IRCCS - Reggio Emilia (Italy)
- 学习椅：Emanuele Zucca, MD、Oncology Institute of Southern Switzerland
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.