A Study to Assess Mitomic Prostate Test for Prostate Canc... | NCT05180305

Studies
A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

NCT05180305

Sponsor

TSH Biopharm Corporation Limited

Status

Unknown status

Last Update Posted

Jan 6, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Mitomic Prostate Test

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2021Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Dec 12, 2021

First Submission Date that Met QC Criteria

Jan 2, 2022

First Posted Date

Jan 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2022

Last Update Posted Date

Jan 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.

Detailed Description

To determine the clinical performance of a blood-based test for clinically significant (CS) prostate cancer (PCa) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (PSA < 10 ng/ml). The test quantifies a previously described 3.4 kb mitochondrial DNA (mtDNA) deletion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Mitomic Prostate Test	Diagnostic Test	Mitomic Prostate Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mitomic Prostate Test (MPT)	To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population.	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
MPT compared to the current standard of care (SOC).	To evaluate optimal disease screening strategies incorporating MPT compared to the current standard of care (SOC).	16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA < 10ng/ml within the previous 3 months.
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:

Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample;
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.

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

To investigate the mitochondrial DNA biomarker in a large group of patients suspicious for prostate cancer to evaluate the Mitomic Prostate Test (MPT)'s accuracy in target population.

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Jane Huang	Contact	0226558525		jane@tshbiopharm.com
Nick Li	Contact	0226558525		Nick_Li@tshbiopharm.com

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms