| CTRI Number |
CTRI/2025/12/099768 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on how blood test changes during cancer surgery influence the risk of surgical complications |
|
Scientific Title of Study
|
Neutrophil Lymphocyte Ratio(NLR) & Albumin - derived Neutrophil Lymphocyte Ratio Score(ANS) in perioperative period of Cancer surgery and its relevance on surgical outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidyashankar C J |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
SR, Dept of Surgical Oncology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449740880 |
| Fax |
|
| Email |
vidyashankarcj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveena Kumar AN |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of Surgical Oncology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9969523579 |
| Fax |
|
| Email |
naveenkumar.an@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vidyashankar C J |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
SR, Dept of Surgical Oncology, KMC Manipal
KARNATAKA
576104
India |
| Phone |
9449740880 |
| Fax |
|
| Email |
vidyashankarcj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Manipal Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 |
| Type of Sponsor |
Private 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 |
| Dr Naveena Kumar AN |
Kasturba Medical College Manipal |
Room No2, Dept of Surgical Oncology
Kasturba Medical College Manipal Udupi
Udupi
KARNATAKA |
9969523579
naveenkumar.an@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C439||Malignant melanoma of skin, unspecified, (2) ICD-10 Condition: C182||Malignant neoplasm of ascending colon, (3) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (4) ICD-10 Condition: C180||Malignant neoplasm of cecum, (5) ICD-10 Condition: C186||Malignant neoplasm of descending colon, (6) ICD-10 Condition: C170||Malignant neoplasm of duodenum, (7) ICD-10 Condition: C601||Malignant neoplasm of glans penis, (8) ICD-10 Condition: C155||Malignant neoplasm of lower thirdof esophagus, (9) ICD-10 Condition: C163||Malignant neoplasm of pyloric antrum, (10) ICD-10 Condition: C20||Malignant neoplasm of rectum, (11) ICD-10 Condition: C37||Malignant neoplasm of thymus, (12) ICD-10 Condition: C184||Malignant neoplasm of transverse colon, (13) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, (14) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult pts undergoing elective cancer surgery
Willing to provide consent |
|
| ExclusionCriteria |
| Details |
Patients with Acute infections
Auto-immune diseases
Immuno-suppressed patients
Palliative surgeries
Non-compliant patients
Recurrent cases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Morbidity post surgery |
within 1 month of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality post surgery |
within 6 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
25/12/2025 |
| 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="1"
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
|
The study is a prospective observational study evaluating Neutrophil Lymphocyte Ratio and Albumin-derived NLR Score as prognostic markers for surgical outcomes in adult cancer surgery patients. It aims to correlate perioperative changes in NLR/ANS with postoperative complications and to assess their impact on long term survival and recurrence All cancer patients over 18 years meeting the inclusion criteria and undergoing surgery in surgical oncology department will be enrolled. Perioperative albumin and NLR/derived-NLR values will be measured within 4 weeks before surgery, and post operative CBCs will be taken on POD 1, 3 and 5 to calculate serial NLR, ensuring at least 4 samples per patient. Post operative complications will be graded using Clavien - Doindo classification, with patients grouped into Major, Grade III or higher, and non major, no complications group, and clinicopathological variables of inflammatory markers will be compared between groups. A total of 1000 patients will be enrolled over a duration of 2 years. Participants will be followed for at least 6months postoperatively to relate biomarker trends to complications, recurrence and survival with the expectation that results will improve perioperative risk stratification and postoperative management |