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CTRI Number  CTRI/2024/12/077643 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   From nutritional factors obtained from blood test of patients with metastatic gastric cancer we will predict the overall survival of such patients 
Scientific Title of Study   Prognostic accuracy of the Hemoglobin,Albumin,Lymphocyte,Platelet (HALP) score in metastatic gastric cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishnu Sureshkumar 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education And Research 
Address  Junior Resident Department of General Surgery JIPMER Campus Raod Gorimedu Dhanvantari nagar PUDUCHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  9544035596  
Fax    
Email  vishnusureshkumar714@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR A Anandhi 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education And Research 
Address  Additional professor Department of Surgery JIPMER Campus Road Gorimedu Dhanvantari nagar PUDUCHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  9487781661  
Fax    
Email  anandhiramesh76@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  DR A Anandhi 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education And Research 
Address  Additional Professor Department of Surgery JIPMER Campus Road Gorimedu Dhanvantari nagar PUDUCHERRY


PONDICHERRY
605006
India 
Phone  9487781661  
Fax    
Email  anandhiramesh76@yahoo.in  
 
Source of Monetary or Material Support  
Jawaharlal Institue Of Postgraduate Medical Education And Research JIPMER Campus Road Gorimedu Dhanvantari Nagar Puducherry India 605006  
 
Primary Sponsor  
Name  Vishnu Sureshkumar 
Address  Junior Resident Department of General Surgery JIPMER Campus Road Gorimedu Dhanvantari Nagar Puducherry 605006 
Type of Sponsor  Other [Self] 
 
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 
DR A Anandhi  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of General Surgery JIPMER Campus Road Gorimedu Dhanvantari Nagar Puducherry,605006
Pondicherry
PONDICHERRY 
9487781661

anandhiramesh76@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Institute of Postgraduate Medical Education And Research Ethics committee for observational studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Retrospective data of patients 18 years of age or older diagnosed with metastatic adenocarcinoma stomach 
 
ExclusionCriteria 
Details  Chronic illness like chronic kidney disease undergoing dialysis
Chronic liver disease
Cardiac failure
Those having secondary malignancies,autoimmune disorders,inflammatory diseases,hematological disorders and active infections
Histology other than adenocarcinoma
Patients with incomplete data in retrospective cohort 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the prognostic accuracy of Hemoglobin, Albumin, Lymphocyte Platelet (HALP) score in predicting overall survival in metastatic gastric cancer patients.  2 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the predictive accuracy of Neutrophil-Lymphocyte Ratio (NLR), Platelet-Lymphocyte Ratio (PLR), and prognostic nutritional index (PNI) individually for overall survival in patients with metastatic gastric cancer.
2.To assess the association of Hemoglobin, Albumin, Lymphocyte Platelet (HALP) score with patient and tumor characteristics like age, sex, ECOG status, comorbidities, surgeries performed tumour pathology, tumour differentiation and location in patients with metastatic gastric cancer. 
2 YEARS 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   10/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After the approval of Institute Ethics Committee, the study will be conducted in the Department of Surgery and Department of Medical Oncology, JIPMER, Puducherry

The details of the patients diagnosed with metastatic gastric cancer (Tumor metastasis in distant organs like liver, lung, parietal peritoneum, nodal metastasis other than regional nodes etc. NCCN, 2024) will be collected from the prospectively maintained retrospective database from January 2013 to December 2022. The patients will be recruited as per the inclusion and exclusion criteria as mentioned above. 

Data related to demography, Eastern Cooperative Oncology Group (ECOG) status, smoking or alcohol consumption habits, comorbidities, pathological type of tumor, site and size of the tumour, endoscopic and CECT findings, Tumor, Node, Metastasis (TNM) staging, chemo radiotherapy regimens given, type and indication for surgeries if any, metastases site, basic blood investigations like hemoglobin, albumin, lymphocyte, and platelets will be obtained from the database and no new investigation will be done on patients.

HALP score will be calculated using laboratory values at time of metastasis (or diagnosis of metastatic disease) by multiplying the hemoglobin albumin and lymphocyte/platelet ratio [hemoglobin (g/L) × albumin (g/L) × lymphocyte count/thrombocyte count]20.

Similarly, Neutrophil/lymphocyte ratio and Platelet/lymphocyte ratio will be calculated as follows.

·        The definition of NLR is the absolute value of neutrophil count (ANC) divided by the absolute value of lymphocyte count (ALC) (NLR = ANC/ALC),

·        PLR is the absolute value of platelet count (PLT) divided by ALC (PLR = PLT/ALC)21.

·        Prognostic Nutritional Index (PNI) will be calculated using the following formula. PNI=(10*serum albumin[g/dl])+(0.005*lymphocyte/microL)22

The overall survival will be calculated as the time from the diagnosis to the date of death.

 

The optimum cut-off point for HALP score will be calculated from the ROC curve and the patients will be categorized into low and high HALP score groups for further analysis.

All the patients will be followed up during the study period for the outcome variable. The minimum follow-up period will be three years and maximum follow-up period will be 10 years or till the outcome event occurs whichever is earliest.  Data regarding mortality will be obtained from records maintained during follow up visits or through telephonic conversation or during routine follow-up visits.

Simultaneously, optimum cut-off value for other prognostic scores like NLR and PLR will be calculated from the ROC curve and their accuracy in predicting overall survival as opposed to HALP score will be analysed.

 

 
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