| CTRI Number |
CTRI/2018/07/015116 [Registered on: 30/07/2018] Trial Registered Prospectively |
| Last Modified On: |
16/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A blood test to detect the presence or absence of cancer |
|
Scientific Title of Study
|
A blood test to determine the probability of developing cancer and/ or its stage, by analysing the
expression profile of molecular immuno-markers in healthy and cancer patients. |
| Trial Acronym |
BTFDC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Astrid Velho |
| Designation |
Chief Physician |
| Affiliation |
Spectrum healthcare |
| Address |
Spectrum HealthCare, 81-84,
Lady Ratan Tata Medical &
Research Centre,
Maharshi Karve Road,
Cooperage, Mumbai
Mumbai
MAHARASHTRA
400021.
India |
| Phone |
022-22846357 |
| Fax |
|
| Email |
avelho@spectrumhealthcare.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Astrid Velho |
| Designation |
Chief Physician |
| Affiliation |
Spectrum healthcare |
| Address |
Spectrum HealthCare, 81-84,
Lady Ratan Tata Medical &
Research Centre,
Maharshi Karve Road,
Cooperage, Mumbai
Mumbai
MAHARASHTRA
400021.
India |
| Phone |
02222846357 |
| Fax |
|
| Email |
avelho@spectrumhealthcare.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Astrid Velho |
| Designation |
Chief Physician |
| Affiliation |
Spectrum healthcare |
| Address |
Spectrum HealthCare, 81-84,
Lady Ratan Tata Medical &
Research Centre,
Maharshi Karve Road,
Cooperage, Mumbai
Mumbai
MAHARASHTRA
400021.
India |
| Phone |
02222846357 |
| Fax |
|
| Email |
avelho@spectrumhealthcare.co.in |
|
|
Source of Monetary or Material Support
|
| Epigeneres Biotech Pvt. Ltd.,
2303, 23rd floor, Fairfield A, Lodha Luxuria, Majhiwada Bridge, Thane(west), Maharashtra-400501, India
|
|
|
Primary Sponsor
|
| Name |
Epigeneres Biotech Pvt Ltd |
| Address |
Unit No. 701, 7th floor, C Wing,
Marathon Innova, Ganpatrao Kadam
Marg, Lower Parel (West),
Mumbai 400037. Maharashtra, India. |
| 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 Astrid Velho |
Spectrum Healthcare |
Spectrum HealthCare, 81-84,
Lady Ratan Tata Medical &
Research Centre,
Maharshi Karve Road,
Cooperage, Mumbai - 400021.
Mumbai
MAHARASHTRA |
022-22846357
avelho@spectrumhealthcare.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clin XXL Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy disease free patients |
| Patients |
Cancer patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Cancer group - Have a type of cancer disease.
2. Healthy group - who are not on any regular medication.
3. Are aged 21 years or older.
4. Are willing to consent to the storage of specimens for
future research.
5. Subjects enrolled will be able to provide informed
consent for themselves. |
|
| ExclusionCriteria |
| Details |
1. Are incarcerated.
2 Are unwilling or unable to comply with prescribed
therapy.
3. Subjects that lack the capacity to provide informed
consent autonomously are to be excluded.
4. Pregnant or lactating women.
5. Subjects who have participated in any clinical trial
in the past 1 month.
6. Any other condition that in the opinion of the
investigator that does not justify the subject’s
participation in the trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expression profile of the molecular immuno-
markers will help in analyzing the probability of manifestation of cancer, before any clinical
symptoms begin to appear in healthy individuals and the development of the disease in
cancer patients. |
0 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The expression profile of the molecular immuno-
markers will help in understanding the efficacious treatment for the cancer patient |
0 days |
|
|
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)
|
31/07/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study was terminated because the protocol required some modification. Total of 24 participants were enrolled in this study. |