| 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
|
|
|
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
|
|
|
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. | |