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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 25 March 2020
Main ID:  CTRI/2019/02/017863
Date of registration: 28-02-2019
Prospective Registration: Yes
Primary sponsor: Datar Cancer Genetics Limited
Public title: Liquid biopsy for prostate lesions
Scientific title: Utility of ProStateTM, the liquid biopsy platform in distinguishing Prostate malignancies from Benign Prostatic Hyperplasia.
Date of first enrolment: 01-03-2019
Target sample size: 300
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31713
Study type:  Observational
Study design:  Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label  
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr Dadasaheb Akolkar   
Address:  First Floor, Department of Research and Innovations, Datar Cancer Genetics Limited, F-8, D Road, MIDC, Ambad, Nasik, Maharashtra 422010 422010 Nashik, MAHARASHTRA India
Telephone:
Email: dadasaheb.akolkar@datarpgx.com
Affiliation:  Datar Cancer Genetics Limited
Name: Dr Dadasaheb Akolkar   
Address:  First Floor, Department of Research and Innovations, Datar Cancer Genetics Limited, F-8, D Road, MIDC, Ambad, Nasik, Maharashtra 422010 422010 Nashik, MAHARASHTRA India
Telephone:
Email: dadasaheb.akolkar@datarpgx.com
Affiliation:  Datar Cancer Genetics Limited
Key inclusion & exclusion criteria
Inclusion criteria: i.Patients with enlarged prostate or elevated PSA or suspicious DRE finding who are therapy naïve.

ii.Age â?¥ 50 years.

iii.Provision of signed and dated informed consent form.

iv.Stated willingness to comply with all study procedures.


Exclusion criteria: Patients who fail to meet all of the above criteria for cases will be excluded. Failing to meet any single criteria would be sufficient grounds for exclusion.

i.Age <50 years.

ii.Active or latent hepatitis B or active hepatitis C or any uncontrolled infection at screening, including (but not limited to) HIV, HPV or tuberculosis.

iii.Patient has an investigational medicinal product within the last 30 days of blood collection.

iv.Personal history of any cancer in the past.

v.Blood transfusion in past 1 month.

vi.(PET-)CT scan in past 14 days.

vii.Patients must have discontinued steroids â?¥ 1 week prior to screening,

NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):

a.Temporary steroid use for CT imaging in setting of contrast allergy,

b.Low dose steroid use for appetite,

c.Chronic inhaled steroid use,

d.Steroid injections for joint disease,

e.Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease,

f.Topical steroids.



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Neoplasms
Intervention(s)
Primary Outcome(s)
To evaluate utility of ProStateTM in distinguishing prostate malignancies from Benign Prostatic Hyperplasia.

Outcome Measure: Positive predictive value of ProStateTM to differentiate prostate malignancies from Benign Prostatic Hyperplasia.

Timepoint: Evaluation Timepoint: Day 0 (Blood sampling at the time of recruitment)
Secondary Outcome(s)
To determine the grade (Gleason Score) of confirmed Ca Prostate.

Outcome Measure: Comparison of Gleason Score with molecular profiling of blood sample.

Timepoint: Evaluation Timepoint: Day 0 (Blood sampling at the time of recruitment)
Secondary ID(s)
NIL
Source(s) of Monetary Support
Canconnect Foundation, Flat No.12, Ameya Sankul, B Wing, Sharanpur Road, Nasik, Maharashtra 422 005
Datar Cancer Genetics Limited, F-8, D Road, MIDC, Ambad, Nasik, Maharashtra 422 010
Secondary Sponsor(s)
Canconnect Foundation
Ethics review
Status: Approved
Approval date: 31/12/2018
Contact:
Datar Cancer Genetics Limited Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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