| CTRI Number |
CTRI/2019/01/017166 [Registered on: 18/01/2019] Trial Registered Prospectively |
| Last Modified On: |
29/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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 (with histologically or cytologically proven malignancy-solid tumors or haematological malignancy) |
| Trial Acronym |
BTDPC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anantbhushan Ranade |
| Designation |
Consultant, Medical Oncology |
| Affiliation |
Sanjeevan Hospital |
| Address |
Sanjeevan Hospital, Plot no. 23, off. Karve Road, Erandwane, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
8380001586 |
| Fax |
|
| Email |
draaranade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anantbhushan Ranade |
| Designation |
Consultant, Medical Oncology |
| Affiliation |
Sanjeevan Hospital |
| Address |
Sanjeevan Hospital, Plot no. 23, off. Karve Road, Erandwane, Pune
MAHARASHTRA
411004
India |
| Phone |
8380001586 |
| Fax |
|
| Email |
draaranade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anantbhushan Ranade |
| Designation |
Consultant, Medical Oncology |
| Affiliation |
Sanjeevan Hospital |
| Address |
Sanjeevan Hospital, Plot no. 23, off. Karve Road, Erandwane, Pune
MAHARASHTRA
411004
India |
| Phone |
8380001586 |
| Fax |
|
| Email |
draaranade@gmail.com |
|
|
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 |
2303, 23rd floor, Fairfield A, Lodha Luxuria, Majhiwada Bridge, Thane(west), Maharashtra-400501, 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 Anant bhushan Ranade |
Sanjeevan Hospital |
Plot no. 23, Off Karve Road,
Near Garware College,
Erandawane, Pune-411004,
Maharashtra
Pune
MAHARASHTRA |
919850817369
draaranade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MTESS Ethics Committe Sanjeevan Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non- Cancer volunteers |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Circulating Tumour Cells and circulating Tumour DNA |
To determine the presence or absence of circulating tumour cells and Circulating tumour DNA |
| Intervention |
HrC Diagnostic Blood test |
To determine the expression and mutation profile of molecular immuno-marker |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Have any type of histologically or cytologically
proven (solid tumors or haematological ) cancer
which will assist in meeting the Primary
objective of this study (Cancer group)
(OR)
ï‚· Individuals who are NOT a known case of any
malignancy( Non-Cancer group)
ï‚· Are aged 18 years or older.
ï‚· Are willing to consent to storage of specimens for
future research.
ï‚· Are willing to comply with study procedures and
follow-ups
ï‚· Subjects enrolled will be able to provide
informed consent for themselves. |
|
| ExclusionCriteria |
| Details |
Are incarcerated.
ï‚· Are unwilling or unable to comply with
prescribed therapy.
ï‚· Subjects that lack the capacity to provide
informed consent autonomously are to be
excluded.
ï‚· Pregnant or lactating women.
ï‚· Subjects who have participated in any clinical
trial in the past 1 month.
ï‚· Any subjects found to have entered into the study
in violation of this protocol or if the subject is
uncooperative during the study
ï‚· 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
|
Computer generated randomization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expression profile of the molecular immuno-
markers will help in analysing the probability of manifestation of cancer, before any clinical
symptoms begin to appear in healthy individuals.
The expression profile of the molecular immuno-markers in cancer patients will help in determining the efficacy of the ongoing
treatment and for cancer survivors it will aid in determining the risk of relapse of the disease. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To follow up with pre-cancer/ high-risk individuals and selected cancer individuals with
telephonic visits every 3 months and conduct blood test at every six months |
five years |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1000" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2019 |
| Date of Study Completion (India) |
31/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Tripathi V, Bhartiya D, Vaid A, Chhabria S, Sharma N, Chand B, Takle V, Palahe P, Tripathi A. Quest for Pan-Cancer Diagnosis/Prognosis Ends with HrC Test Measuring Oct4A in Peripheral Blood. Stem Cell Rev Rep. 2021 May 6. doi: 10.1007/s12015-021-10167-1. Epub ahead of print. PMID: 33954878 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Tumor markers are substances, often proteins, that are produced by the cancer tissue itself or sometimes by the body in response to cancer growth. Because some of these substances can be detected in body samples such as blood, urine, and tissue, these markers may be used, along with other tests and procedures, to help detect and diagnose some types of cancer, predict and monitor a person’s response to certain treatments, and detect recurrence. Novel tests have been developed that look for changes in genetic material (DNA, RNA), rather than proteins, in cancer patient samples. The genetic changes have been found to be associated with certain cancers and can be used as tumor markers to help determine prognosis, guide targeted treatment, and/or detect cancers early on. Moreover, advances in technology have led to tests that can evaluate several genetic markers or panels of markers at the same time, providing expanded information about the characteristics of a tumor.
This study is conducted to determine the probability of developing cancer and/ or its stage, by analyzing the expression profile of molecular immuno-markers in the peripheral blood sample of healthy and cancer patients
Study Objectives: Primary: 1. To evaluate the expression profile of Molecular Immuno-markers in the peripheral blood of healthy and cancer patients 2. To evaluate Circulating tumor DNA in the peripheral blood of healthy and cancer patients
Secondary : To follow up with pre-cancer/ high-risk individuals and selected cancer individuals with telephonic visits every 3 monthly and conduct blood test at regular intervals. |