| CTRI Number |
CTRI/2025/10/096375 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analyzing the use of cardiac biomarker(H-FABP) in assessment of chemotherapy related cardiac side effect |
|
Scientific Title of Study
|
Evaluating the utility of H-FABP to predict cardiac dysfunction in cancer patients on Anthracycline chemotherapy, Her 2 Targeted therapy and Immunotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranav Gopal Jawade |
| Designation |
Registrar in medical oncology |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Room No: 06, 4th floor, Department of Medical oncology, Shridi saibaba cancer block, Kasturba Medical Colege and Hospital, Manipal, Karnataka
NA
Udupi
KARNATAKA
576104
India |
| Phone |
9423105363 |
| Fax |
|
| Email |
dr.pranavjawade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ananth Pai |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Room No: 04, 4th floor, Department of Medical oncology, Shridi saibaba cancer block, Kasturba Medical Colege and Hospital, Manipal, Karnataka
NA
Udupi
KARNATAKA
576104
India |
| Phone |
9880239139 |
| Fax |
|
| Email |
ananth.pai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pranav Gopal Jawade |
| Designation |
Registrar in medical oncology |
| Affiliation |
Kasturba Medical Colege and Hospital |
| Address |
Room No: 06,4th floor, Department of Medical oncology, Shridi saibaba cancer block, Kasturba Medical Colege and Hospital, Manipal, Karnataka
NA
Udupi
KARNATAKA
576104
India |
| Phone |
9423105363 |
| Fax |
|
| Email |
dr.pranavjawade@gmail.com |
|
|
Source of Monetary or Material Support
|
| 4th floor, Department of Medical oncology, Shridi saibaba cancer block, Kasturba Medical Colege and Hospital, Manipal, Karnataka
|
|
|
Primary Sponsor
|
| Name |
Pranav Gopal Jawade |
| Address |
Room No: 08, 4th floor, Department of Medical oncology, Shridi saibaba cancer block, Kasturba Medical Colege and Hospital, Manipal, Karnataka |
| 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 |
| Pranav Gopal Jawade |
Kasturba Medical College and Hospital |
4th floor, No: 06, Department of Medical Oncology
Shiri Saibaba cancer hospital, near Tiger circle
Kasturba Medical College and Hospital
Udupi
KARNATAKA |
9423105363
dr.pranavjawade@gmail.com |
|
|
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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 years and both genders.
Histologically diagnosed metastatic and non-metastatic carcinoma planned for Anthracycline-
based Chemotherapy, Immunotherapy & HER 2 NEU targeted therapy. |
|
| ExclusionCriteria |
| Details |
Any previous existing LV dysfunction.
Any pre-existing ischemic heart disease, Arrhythmias, and congenital heart disease.
Any history of previously treated or ongoing treatment of heart failure.
Gross derangement in any metabolic parameters that can affect GLS, like sepsis and anemia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome
To determine the H FABP as a cardiac biomarker in predicting cardiac dysfunction among cancer patients associated with Anthracycline chemotherapy, Immunotherapy and HER 2 NEU targeted therapy
Secondary Outcome
To Find co-relation between H FABP and other cardiac biomarkers like Trop T and NT-pro BNP with GLS AVG to detect the cardiac toxicity associated with Anthracycline chemotherapy,
Immunotherapy and HER 2 NEU targeted therapy |
Baseline, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/11/2025 |
| 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
|
This prospective cross-sectional study aims to evaluate the utility of Heart-type Fatty Acid Binding Protein (H-FABP) as an early biomarker for detecting cardiac dysfunction in cancer patients undergoing Anthracycline-based chemotherapy, HER2-targeted therapy, and Immune Checkpoint Inhibitor (ICI) treatment. A total of 100 patients will be enrolled over one year and assessed for cardiac toxicity using H-FABP, Troponin I/T, CK-MB, NT-proBNP, and CRP at baseline, 3 months, and 6 months. Cardiac function will be evaluated using ECG and 2D Echocardiography with Global Longitudinal Strain (GLS). The study will explore the correlation between H-FABP and other biomarkers with GLS changes to determine their predictive value for subclinical cardiotoxicity. Given the high mortality associated with ICI-related myocarditis and the known cardiotoxic potential of anthracyclines and HER2 therapies, early detection is critical. H-FABP, due to its rapid release following myocardial injury, may offer a sensitive tool for early intervention, potentially reducing treatment interruptions and improving patient outcomes. Statistical analysis will involve ANOVA and correlation tests, with significance set at p<0.05. The findings could support integrating H-FABP into routine monitoring protocols, enhancing cardioprotection and allowing safer, uninterrupted cancer therapy delivery. |