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临床试验/NCT02759718
NCT02759718Unknown4 期

Clinical Effectiveness of Serum Chromogranin A (CgA) Levels on Diagnostic Relevance, Response After Surgical Resection and Recurrence of Pancreatic Endocrine Tumors (PET)

Asan Medical Center0 个研究点目标入组 111 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
4 期
入组人数
111
主要终点
Diagnostic accuracy of th CgA in the patient with PNET, change from preoperative levels of CgA at 3 months

研究概览

简要总结

Chromogranin A (CgA) is a glycoprotein with a molecular weight of 49 to 52 kDa produced by chromaffin cells of the adrenal medulla, enterochromaffin-like (ECL) cells, and endocrine cells of the stomach and pancreas, and it is the precursor to several functional peptides including vasostatin and pancreastatin.

Importantly, CgA can be measured in the serum or plasma or detected within the secretory vesicles as a general diagnostic biomarker for neuroendocrine tumors (NETs), and plasma CgA levels also provide information regarding tumor burden and response to treatment. It has a sensitivity and specificity between 27% and 81%.

Some studies have noted an association between CgA concentrations and tumor location or degree of differentiation. It has also been proposed that plasma CgA levels are more frequently elevated in well-differentiated tumors compared with poorly differentiated tumors of the midgut. Some other clinical series have provided evidence of an association between plasma CgA levels and the extent of disease, tumor burden, or presence of metastases, and high baseline levels of CgA are suggestive of a poor prognosis.

However, there exist still controversies the effectiveness of serum CgA levels on diagnostic relevance, treatment response after surgical resection or sandostatin analog, clinicopathologic features of pancreatic neuroendocrine tumors (PNETs).

To date, moreover, a precise association between CgA levels and survival has not been clearly demonstrated, although a number of studies suggest that this relationship may exist. There, especially, is no relevant data on value of serum CgA level for clinical usefulness in Korean population.

详细描述

An interventional, prospective, multi center pilot study to assess the clinical relevance of CgA levels in patients with PNET as performed in current clinical practice.

There will be a measurement of CgA levels at baseline (preoperative measures after consent) and afterwards, in 3, 6, 12, and 24 months after resection. Immunoradiometric assay (IRMA, normal values: < 100 ng/mL) will be used.

The collection of blood samples will proceed as detailed below:

Extraction of samples for serum collection:

7 ml of blood without anticoagulants will be allowed to sit for 30 min at room temperature before the serum is separated by centrifugation (3500 rpm). The serum will be stored at -20ºC

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having differential diagnosis with PNET in preoperative radiologic diagnosis
  • Life expectancy is equal or more than 6 months
  • whom written informed consent to participate in the study

排除标准

  • renal insufficiency
  • taking proton pump inhibitor
  • cardiac insufficiency grade 3 and 4
  • chronic atrophic gastritis.
  • multiple endocrine neoplasia or Cushing's syndrome or mixed tumours or pheochromocytoma or medullary thyroid carcinoma.
  • previous history of malignant tumour, with the exception of carcinoma in situ of the uterine cervix or non-melanoma skin cancer
  • whom cannot be followed up during the study because of psychology or geographic reasons.

结局指标

主要结局

Diagnostic accuracy of th CgA in the patient with PNET, change from preoperative levels of CgA at 3 months

时间窗: preoperation, 3 months

In the PNET group, the plasma level of CgA was regularly measured.

次要结局

  • Diagnostic accuracy of th CgA in the patient with disease progression, change from preoperative levels of CgA at 3, 6,12, and 24 months(preoperation, 3 months, 6 months, 12months, 24 months)
  • Disease progression of PNET using CT imaging, change from preoperative imaging of CT at 3, 6,12, and 24 months(preoperation, 3 months, 6 months, 12months, 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Song Cheol Kim

professor

Asan Medical Center

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