ITANET -Registry: Multicentric Collection of Cases on Neuroendocrin Gastro-Entero-Pancreatic Tumors (Title in Local Language: ITANET -Registry: Raccolta Multicentrica Dei Casi di Tumore Neuroendocrino Gastro-Entero-Pancreatico)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,600
- 试验地点
- 35
- 主要终点
- Different localisations of primary GEP-NET
研究概览
简要总结
This is a prospective observational study with the aim to create an Italian database for the collection of data on diagnostic approach, therapy and follow up of patients affected by GEP-NET (gastro-enteric-pancreatic neuroendocrine tumours). Data for approximately 200 italian patients were already previously collected in the ENETS database (international database). ENETS decided to interrupt the collection of the data for an indefinite period. For this reason, through an amendment (number 1) to the protocol, ITANET (Italian Association Neuro-endocrine Tumors) decided to transfer the italian data into a national database and to go on with the collection/update of the data, in order not to lose important clinical information.
详细描述
Each participating site will have access through the reserved area of webpage https://itanetdb.fullcro.org/, for the data recording in a database which ITANET set-up for the participating sites in Italy.
The eligible patients, visited at each participating site, will be asked to adhere to the ITANET-project through a proper Informed Consent obtainment procedure.
Adequate procedures are described in the protocol amendment 1 (and in a proper Standard Operating Procedure) also for the management of the already collected data in the previous ENETS registry whose transferral/update/deletion in the ITANET database are well defined and regulated in order to respect and preserve the patients' rights.
The data will be collected in an pseudo-anonymised way. Each patient will be identified by a code.
The data management and quality check of the Italian data is deputed to ITANET. The data will be collected in a prospective way, both for the new diagnoses (first visits) and for the follow up visits of patients with already acquired diagnosis. For the patients with already acquired diagnosis, these diagnostic data can be collected retrospectively, but not earlier than 1 year from the date of informed consent signature.The enrolment will take place during the outpatient visit or at the time of the hospitalisation for the NET-related surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •age> or = 18 years;
- •histologically/cytologically proved diagnosis of NET OR diagnosis supported by a PET Gallium 68 positivity and by at least a contrastografic imaging of second level (CT scan or NMR);
- •Diagnosis of GEP-NET not antecedent 1 year since the Informed Consent signature;
- •Grading G1, G2, G3 according to the classification WHO 2019;
- •Tumor origin in digestive apparatus (GEP NETs) or tumor of unknown origin;
- •Signed Informed consent.
排除标准
- •Known tumor origin different from digestive apparatus (GEP NETs);
- •no evidence of histologically/cytologically proved diagnosis of NET OR diagnosis supported by a PET Gallium 68 positivity and by at least a contrastografic imaging of second level (CT scan or NMR);
- •Diagnosis of GEP-NET antecedent 1 year since the Informed Consent signature.
结局指标
主要结局
Different localisations of primary GEP-NET
时间窗: 3 years
Time between symptoms appearance and diagnosis of GEP-NET
时间窗: 3 years
Incidence of GEP-NET in Italy
时间窗: 3 years
Type of used and available treatments (medical and surgical)
时间窗: 3 years
次要结局
未报告次要终点