| CTRI Number |
CTRI/2020/10/028608 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Development of AXTEX-4D, a unique system to grow solid tumor outside body for clinically relevant studies and treatment protocol analysis |
|
Scientific Title of Study
|
Assessment of Growth of primary cells form solid tumors on Axtex-4D, the Ex vivo tissueoid generator platform |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nupur Mehrotra |
| Designation |
Director |
| Affiliation |
Premas Biotech Pvt Ltd |
| Address |
Premas Biotech Pvt Ltd
Plot 77
Sector 4
IMT Manesar
Gurgaon
HARYANA
122050
India |
| Phone |
01244546600 |
| Fax |
|
| Email |
nupur.mehrotra@premasbiotech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Biswa P Das Purkayastha |
| Designation |
Research Scientist |
| Affiliation |
Premas Biotech Pvt Ltd |
| Address |
Premas Biotech Pvt Ltd
Plot 77
Sector 4
IMT Manesar
Gurgaon
HARYANA
122050
India |
| Phone |
01244546600 |
| Fax |
|
| Email |
biswa.pratim@premasbiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashok Jain |
| Designation |
Head Finance |
| Affiliation |
Premas Biotech Pvt Ltd |
| Address |
Premas Biotech Pvt Ltd
Plot 77
Sector 4
IMT Manesar
Gurgaon
HARYANA
122050
India |
| Phone |
01244546600 |
| Fax |
|
| Email |
ashok.jain@premasbiotech.com |
|
|
Source of Monetary or Material Support
|
| Premas Biotech Pvt Ltd
Plot 77
Sector 4
IMT Manesar
Haryana 122050 |
|
|
Primary Sponsor
|
| Name |
Premas Biotech Pvt Ltd |
| Address |
Plot N0 77
Sector 4
IMT Manesar
Gurgaon
Haryana |
| Type of Sponsor |
Other [Technology Platform Development] |
|
|
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 Harit Chaturvedi |
Max Super Speciality Hospital Saket |
1 2 Press Enclave Marg Saket Institutional Area Saket
New Delhi
DELHI |
8860444888
harit.chaturvedi@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Devki Devi Foundation |
Approved |
| Premas Biotech Pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Absence of long term/chronic disease will be preferred
2. Sample cohort should be an heterogenous mixture of individuals from different demographic regions of the country with difference in ethnic and racial origin
3.Treatment naïve individuals
|
|
| ExclusionCriteria |
| Details |
1.Tissues from terminally ill patient.
2.Not require treatment-experienced or prior-treatment-failed “salvage†participants tumor.
3.Size <100 mg
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Development of tissueoid generation platform, AXTEX-4D, that shall aid in growing tumor tissues ex vivo |
Not Applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
26/10/2020 |
| 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
|
Not Available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed research study involving development of tissueoid generation
platform (Axtex-4D) that shall aid in growing tumor tissues ex vivo, mimics
the in vivo tumor properties for clinically relevant studies and treatment
protocol analysis |