| CTRI Number |
CTRI/2025/09/095113 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of concentration of various fats in the blood of children who have a specific blood cancer (ALL) to understand how the disease affects the response of their body |
|
Scientific Title of Study
|
Fatty acid profile in pediatric B type ALL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kritika Pandey |
| Designation |
Student |
| Affiliation |
KMC,Manipal |
| Address |
Department of Biochemistry ,KMC Manipal
Ishwar Nagar , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8755204944 |
| Fax |
|
| Email |
kritika.kmcmpl2024@learnersa.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishnananda Prabhu R.V |
| Designation |
Professor |
| Affiliation |
KMC,Manipal |
| Address |
Department of Biochemistry ,KMC Manipal
Ishwar Nagar , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844380157 |
| Fax |
|
| Email |
krishnananda.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kritika Pandey |
| Designation |
Student |
| Affiliation |
KMC,Manipal |
| Address |
Department of Biochemistry ,KMC Manipal
Ishwar Nagar , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8755204944 |
| Fax |
|
| Email |
kritika.kmcmpl2024@learnersa.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kritika Pandey |
| Address |
Department of Biochemistry KMC Manipal Madhav Nagar, Manipal 576104 |
| 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 |
| Kritika Pandey |
Kasturba Medical College |
Department of Biochemistry, KMC Manipal
Udupi
KARNATAKA |
08755204944
kritika.kmcmpl2024@learnersa.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All newly diagnosed cases of B type ALL from birth to 18 years |
|
| ExclusionCriteria |
| Details |
Other types of ALL
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum fatty profile will be associated with treatment outcomes, demographic details & cytogenic profile may help in forecasting future occurrence of disease |
Baseline: Collection of blood samples from participants newly diagnosed with ALL
6 months: Fatty avid profiling of the blood sample of participants with ALL
12 months: Association of fatty acid levels with demographics, disease characteristics, and treatment response. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/10/2025 |
| 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 Yet Recruiting |
| 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
|
Fatty acid play key role in cell growth, membrane structure & energy metabolism and there is limited data on how these fatty acid changes related to demographic factors, cytogenetic profiles, flow cytometry data & treatment outcomes Leftover serum samples from newly diagnosed pediatric B - ALL patients will be collected at diagnosis & after initial steroid therapy. Samples are stored at -80 degree Celsius.t, processed & analyzed using GC-MS for fatty acid profiles. These will be correlated with demographics, cytogenetics, flow cytometry & disease outcomes. Correlating these & clinical data may help identify new biomarkers for diagnosis, prognosis & risk stratification in pediatric B - ALL. It may fill the current gap in research, as very few studies have comprehensively examined FA metabolism in relation to cytogenetics & treatment outcomes. Results could help in predicting prognosis, stratifying risk & potentially guiding treatment approaches. |