A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
NCT ID: NCT05180305
Last Updated: 2022-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-04-27
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Mitomic Prostate Test
Mitomic Prostate Test
Eligibility Criteria
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Inclusion Criteria
* Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available.
* Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available;
* The index biopsy must occur following and within 16 weeks of blood draw.
Exclusion Criteria
* Previous diagnosis of prostate cancer;
* Prostate biopsy within the previous 3 months;
* Men with a total PSA\>10ng/ml within the previous 3 months;
* Provides less than the required amount of blood;
* Considered incompetent to provide informed consent;
* Does not understand and read language of informed consent;
* Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable;
* Males who are not of screening age (\<45);
* Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP);
* Blood collected after index biopsy.
* Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.
45 Years
MALE
No
Sponsors
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TSH Biopharm Corporation Limited
INDUSTRY
Responsible Party
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Locations
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Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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TSHMPT2001-P
Identifier Type: -
Identifier Source: org_study_id
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