跳至主要内容
临床试验/CTRI/2019/03/018064
CTRI/2019/03/018064尚未招募不适用

Assessment of tumor markers; CA-19-9, CEA,CA125, CA242 for early diagnosis and predicting prognosis in gall bladder cancer patient

Director1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Access whether the combined use of tumor markers increase the diagnostic sensitivity and specificity for gallbladder cancer

研究概览

简要总结

Gallbladder cancer (GBC) is one of the most common and aggressive cancer in South East Asia. IT is very difficult to diagnose gallbladder cancer in early stage as it is lacks typical clinical early manifestation leading to poor 5 years survival outcome. Most of the patients presented at advanced stage and thus lose the chance of radical cure. It is important to diagnose GBC as early as possible. Presently diagnosis of GBC mainly depends upon radiological imaging like Ultrasonography, CAT Scan and MRI, PET Scan and invasive examination such as FNAC, trucut biopsy and laparoscopy. However there is no established ideal single tumor marker for diagnosis and prognosis of GBC. The incidence of GBC in India is very high and one of the leading cancer , among male it stand second to oral cancer while in female it shares third place along with oral cavity cancer the first two being cervix and breast cancer.

The tumor markers such as CEA, CA 125, CA19-9, CA 242, AFP have been widely used for different type of cancer (e.g. Liver, gastric, colorectal, ovarian and pancreatic). However these markers are used individually for diagnosis of GB cancer inconsistent result has been observed.

AIM AND OBJECTIVE

1.     The aim of this study to access whether the combined use of tumor markers increase the diagnostic sensitivity and specificity for gallbladder cancer

2.     To compare the tumor marker level before and after surgical management of GBC

3.     To help in taking clinical decision in management of carcinoma gall bladder.

All patients suspicious of GBC (gallbladder polyp, irregular wall thickening with or without gall stone, GB mass) on basis of radiological imaging ( USG, CT scan, MRI, PET scan) coming to outpatient department of GI surgery, General surgery and RCC will be enrolled for this study as per inclusion and exclusion criteria. Approval of from ethical committee of the institute will be obtained. A patient performa having information like name, age, sex ,BMI, complete clinical details radiological finding and laboratory parameter( CBC, FBS, LFT, KFT, Tumor markers; CA 125, CA19-9, CEA, CA 242) will be recorded for every patent. The venous blood sample in fasting will be collected from each patient after informed consent. The patient who will undergo surgical management ( Radical Cholecystectomy) will be called for follow up at 3 moth and 6 month. All GBC diagnoses will confirmed pathologically. During each follow up clinical finding, radiological finding and value of tumor marker and other laboratory will be recorded.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients suspicious for gallbladder cancer ( GB polyp, irregular thick wall GB, GB mass, porcelain GB) basis of radio logical imaging.

排除标准

  • 1.Patients presented with GB mass with Jaundice 2.Disseminated GBC 3.Patients already received Radiotherapy/ Neoadjuvant chemotherapy 4.Synchronous second primary cancer.

结局指标

主要结局

Access whether the combined use of tumor markers increase the diagnostic sensitivity and specificity for gallbladder cancer

时间窗: 15th April 2019 (At 1 year)

次要结局

  • To compare the tumor marker level between carcinoma of gall bladder and benign gall bladder diseases.(January 20121 (at 2 years))

研究者

发起方
Director
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验

Tumor Marker CA-19-9, CEA,CA125, CA242 for early... | 临床试验