| 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
|
|
|
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
|
|
|
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. |