| CTRI Number |
CTRI/2025/03/081548 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Tracking Colorectal Cancer with Blood Tests: Using CTCs and ctDNA Compared to Traditional Methods. |
|
Scientific Title of Study
|
Longitudinal Monitoring Circulating Tumour Cells(CTC) and Circulatory Tumour DNA (Ctdna) Load in Metastatic colorectal Cancer( Mcrc) and Comparative Analysis with Conventional Assessment Methods. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi S |
| Designation |
Consultant-Medical Oncologist |
| Affiliation |
Aster CMI Hospital |
| Address |
Aster CMI Hospital
NO.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
9916138628 |
| Fax |
|
| Email |
vaishnavi.s@asterhospital.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi S |
| Designation |
Consultant-Medical Oncologist |
| Affiliation |
Aster CMI Hospital |
| Address |
Aster CMI Hospital
NO.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
KARNATAKA
560092
India |
| Phone |
9916138628 |
| Fax |
|
| Email |
vaishnavi.s@asterhospital.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSurinder Kher |
| Designation |
Executive Head-Clinical Research |
| Affiliation |
Aster CMI Hospital |
| Address |
Aster CMI Hospital
NO.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
08043420940 |
| Fax |
|
| Email |
research.aster@asterhospital.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aster CMI Hospital |
| Address |
NO.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Vaishnavi S |
Aster CMI Hospital |
NO.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA |
9916138628
vaishnavi.s@asterhospital.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster CMI Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D898||Other specified disorders involving the immune mechanism, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age above 18years
2.Performance status 0-1
3.Hisologically confirmed invasive colorectal adeno carcinoma
4.Measuramble metastatic disease/M1/STAGE 4colorectal cabncer
5. Patient willing to give informed consent.
6. |
|
| ExclusionCriteria |
| Details |
1.Patients diagnosed with stage 1-3 colorectal cancer
2.Poor performance status
3.Patient not willing or not planned for definitive management of colorectal cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rudimentary data on utility of CTC and CtDNA in treatment monitoring
in metastatic colorectal cancers. |
Collection of blood samples at 0 weeks of planned treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. CTC levels in comparison with conventional response assessment
methods like Serum CEA & cross sectional imaging.
2. To explore simple, cost effective solutions in personalized medicine. |
Collection of blood samples at 6,12 weeks of planned treatment |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
10/03/2025 |
| 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
|
-Proposed prospective study, Out patient clinics and in patient wards of all 3 hospitals
-To be conducted in 3 centres of Aster hospital Bangalore- Cmi,
Hebbal,Whitefeild and RV. The study will includes
1.Collection of plasma samples (20ml) from 15 patients diagnosed with
metastatic colorectal cancer at 0, 6 and 12 weeks of planned treatment which
may include (Palliative chemotherapy, biological therapy , targeted therapy
or immunotherapy, surgery and radiation treatment in some cases) 2.Samples subjected to measurement of Circulating tumor DNA, cTDNA load
and analysis of pertinent mutations using the iCAn monitor capture assay.
This platform contains affinity-based magnetic nanoparticles to mediate
EpCAM- based CTC isolation. 3.This longitudinal monitoring and results/responses to treatment will be
compared to conventional response assessment methods like Serum CEA
measurements and PET CTscan / CT scans (done at 12 weeks as a standard
practice in our institution) to guide treatment strategies in metastatic
colorectal cancer using statistical methods.
Period of recruitment: 1 year
Outcome variables : 1.Detection, levels of CTC and cTDNA load at various time points 2.Correlation with Response assessment using CT scan / PET CT scan 3.Additional assessment – pertinent mutations in liquid biopsy, prevalence
and their influence on outcomes . |