Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This is a retrospective/prospective observational multicentric trial on patients with bone metastases from NENs.
General objectives:
- To trace on a national scale the frequency of bone metastases in patients with neuroendocrine neoplasm (NEN) and their clinical management.
- To correlate clinical and biological factors to clinical outcomes.
- To centralise and to make homogeneous clinical, pathological, instrumental and therapeutic information.
- To set up a database and to acquire biological material for studying predictive and prognostic biomarkers.
详细描述
Background, rationale and objectives:
On March 25th 2015 the Ethical Committee from IEO approved the academic study entitled "Bone metastases in neuroendocrine tumors (NETs): a survey on natural history, prognostic value and treatment approach", version 1.0 30-Jan-2015. This was a retrospective study led to report how the issue bone metastases from NETs was handle in real practice. Preliminary data related to 321 patients from 18 Italian centers were presented as a poster at the ESMO 2017 congress (Fazio et al. 448P) and they will be included in a manuscript to submit for publication in a peer-review journal. The current protocol regards the continuation of the retrospective analysis, starting since 2014, since the previous study required data collection up to 2013, and at the same time a multicenter prospective observational analysis on the topic.
Duration of the study The study will regard patients fulfilling the eligibility criteria from 2014 to 2021. Data analysis will be completed by the year 2021.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of NEN
- •Instrumental and/or histological diagnosis of bone metastasis
- •At least one year of follow-up from the diagnosis of bone metastasis
排除标准
- •Small cell lung carcinoma
- •Non neuroendocrine neoplasm
结局指标
主要结局
Overall survival
时间窗: 01/2021 - 12/2021
Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death
Correlation between SRE and time from bone metastasis and SRE, site of one metastases, number of bone metastases, morphology of bone metastases, LDH
时间窗: 01/2021 - 12/2021
To evaluate the correlation between SRE and time from bone metastasis and SRE, site of one metastases, number of bone metastases, morphology of bone metastases, LDH
Influence of skeletal related events (SRE) on survival
时间窗: 01/2021 - 12/2021
Influence of skeletal related events (SRE) on overall survival (OS)
Influence of the use of bisphosphonates or RANK-ligands
时间窗: 01/2021 - 12/2021
To evaluate the influence of the use of bisphosphonates or RANK-ligands on overall survival
次要结局
- Radiological diagnosis (CT, MRI)(01/2021 - 12/2021)
- Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT)(01/2021 - 12/2021)
- Correlation from bone metastases and age, gender, primary site, Ki-67, grade of differentiation(01/2021 - 12/2021)
- Impact of antitumor therapy on bone metastases behavior(01/2021 - 12/2021)
- Natural history (time between diagnosis of NEN and first diagnosis of bone metastasis, frequency and time to SRE, sites of bone metastases)(01/2021 - 12/2021)
- Impact of supportive care(01/2021 - 12/2021)