Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
None listed
Sponsors
Datar Cancer Genetics Limited
Canconnect Foundation
Eligibility
Inclusion criteria
Inclusion criteria: i.Patients with enlarged prostate or elevated PSA or suspicious DRE finding who are therapy naïve. ii.Age >= 50 years. iii.Provision of signed and dated informed consent form. iv.Stated willingness to comply with all study procedures.
Exclusion criteria
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 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 >= 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
India
Contacts
Public ContactDr Dadasaheb Akolkar
Datar Cancer Genetics Limited
Outcome results
None listed