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CTRI Number  CTRI/2019/03/018064 [Registered on: 13/03/2019] Trial Registered Prospectively
Last Modified On: 11/03/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Tumor Marker CA-19-9, CEA,CA125, CA242 for early diagnosis and predicting prognosis in gall bladder cancer patient 
Scientific Title of Study   Assessment of tumor markers; CA-19-9, CEA,CA125, CA242 for early diagnosis and predicting prognosis in gall bladder cancer patient 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SEEMA RANI SINHA 
Designation  Junior Resident 
Affiliation  Indira Gandhi Institute Of Medical Sciences  
Address  Department of Biochemistry New Building Sheikhpura Bailey Road

Patna
BIHAR
800014
India 
Phone  9801276737  
Fax    
Email  drsrsinha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PREM PRAKASH 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute Of Medical Sciences  
Address  Department of General Surgery Sheikhpura Bailey Road

Patna
BIHAR
800014
India 
Phone  9801276237  
Fax    
Email  drpremprakash01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PREM PRAKASH 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute Of Medical Sciences  
Address  Department of General Surgery Sheikhpura Bailey Road

Patna
BIHAR
800014
India 
Phone  9801276237  
Fax    
Email  drpremprakash01@gmail.com  
 
Source of Monetary or Material Support  
IGIMS Sheikhpura Bailey Road Patna- 800014 
 
Primary Sponsor  
Name  Director 
Address  Indira Gandhi Institute of Medical Sceinces Sheikhpura, Patna 800014 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Seema Rani Sinha  Indira Gandhi Institute of Medical Sciences  Department of Biochemistry, GI Surgery and General Surgery Bailey Road, Patna 800014
Patna
BIHAR 
9801276737

drsrsinha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K828||Other specified diseases of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients suspicious for gallbladder cancer ( GB polyp, irregular thick wall GB, GB mass, porcelain GB) basis of radio logical imaging 
 
ExclusionCriteria 
Details  1.Patients presented with GB mass with Jaundice
2.Disseminated GBC
3.Patients already received Radiotherapy/ Neoadjuvant chemotherapy
4.Synchronous second primary cancer
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Access whether the combined use of tumor markers increase the diagnostic sensitivity and specificity for gallbladder cancer   15th April 2019 (At 1 year) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the tumor marker level between carcinoma of gall bladder and benign gall bladder diseases.  January 20121 (at 2 years) 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.


 
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