| CTRI Number |
CTRI/2023/04/052111 [Registered on: 28/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A simple blood test to understand presence or absence of cancer |
|
Scientific Title of Study
|
Screening of cancer from peripheral blood sample through different stem
cell-based tests |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepan Bhartiya |
| Designation |
Lab Director |
| Affiliation |
Epigeneres Biotech Pvt Ltd |
| Address |
Epigeneres Biotech Pvt Ltd.
1st floor, Todi Bldg., Mathuradas mill compound, Senapati Bapat Marg, Lower Parel west, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
deepa.bhartiya@epigeneres.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshama Pansare |
| Designation |
VP- Research & Development |
| Affiliation |
Epigeneres Biotech Pvt Ltd |
| Address |
Epigeneres Biotech Pvt Ltd.
Ikon House , B-Block, Sun mill compound, Senapati Bapat Marg, Lower Parel west, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
kshama@epigeneres.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshama Pansare |
| Designation |
VP- Research & Development |
| Affiliation |
Epigeneres Biotech Pvt Ltd |
| Address |
Epigeneres Biotech Pvt Ltd.
Ikon House , B-Block, Sun mill compound, Senapati Bapat Marg, Lower Parel west, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
kshama@epigeneres.com |
|
|
Source of Monetary or Material Support
|
| Epigeneres Biotech Pvt Ltd,
1st floor, Todi Bldg., Mathuradas Mill Compound, Senapati Bapat Marg, Lower Parel west , Mumbai |
|
|
Primary Sponsor
|
| Name |
Epigeneres Biotech Pvt Ltd |
| Address |
Epigeneres Biotech Pvt Ltd,
1st floor, Todi Bldg., Mathuradas Mill Compound, Senapati Bapat Marg, Lower Parel west , Mumbai |
| Type of Sponsor |
Other [Biotechnology Company] |
|
|
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 Kshama Pansare |
Epigenere Biotech Pvt Ltd |
1st floor, Research Department, Todi Bldg. Mathuradas Mill Compound, Senapati Bapat Marg, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA |
9552084069
kshama@epigeneres.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| V-Care Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18-70years, Non cancer participiants |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Test |
Molecular analysis of peripheral blood samples through different proprietary techniques to understand presence or absence of malignancy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals:
1. 18 years and above healthy individuals will be
included in the study.
2. Individuals with no prior history of cancer will be
included.
Cancer patients:
1. 18 years and above cancer patients will be included
in the study.
2. Cancer patients will be confirmed on histopathology
irrespective of grade and stage. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Age less than 18 years.
2. Verified biohazard samples will be excluded.
3. Cancer subjects who have received anticancer
treatment within 7 days of sample collection
4. Subjects who have undergone surgery within
previous 2 weeks of sample collection
5. Pregnant/ lactating females
6. Subjects who have received growth factors in past 2
weeks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identification of cancer and non-cancer subjects using biochemical fingerprints of
Raman Spectroscopy, gene expression patterns of qPCR and rare stem cells
enumeration using Flow cytometry.
• Identification of primary impacted organ using altered gene expression patterns and
mutations profile wherever applicable. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
08/05/2023 |
| 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)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: Screening of cancer from Peripheral blood sample through different stem cell-based tests
Milestone to be achieved- Collation of data (n=500 subjects including non-cancer individuals and cancer subjects) different phases of study like optimisation and validation.
Objectives: 1. To assess the feasibility of Raman Spectroscopy as a screening tool for cancer detection 2. To isolate circulating stem cells from peripheral blood of cancer and non-cancer subjects and determine expression patterns of various markers by quantitative QPCR. 3. To isolate and enumerate rare/stem cells from peripheral blood of healthy individuals and cancer patients (Flow Cytometry). 4. To assess the potential of AOB test (Next Generation Sequencing of stem cells/ cancer stem cells/ progenitors enriched from the peripheral blood) for identification of exomic and transcriptomic profile of primary impacted organ.
Exploratory objective: 1. To identify the cancer subtype and metastatic site using AOB test. |