Assessing Circulating Tumor Cell as a Biomarker for Prost... | NCT03488706

Studies
Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level

NCT03488706

Sponsor

CellMaxLife

Status

Unknown status

Last Update Posted

Apr 5, 2018Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

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

Mar 2018

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

Jan 17, 2018Actual

Primary Completion Date

Dec 12, 2018Estimated

Completion Date

Jun 2, 2021Estimated

First Submitted Date

Mar 29, 2018

First Submission Date that Met QC Criteria

Mar 29, 2018

First Posted Date

Apr 5, 2018Actual

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

Mar 29, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gray Zone Group		The gray zone group PSA between 4.00 to 10.99 ng/ml.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circulating tumor cells detection	Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level	Prior to prostate biopsy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects are willing to sign the informed consent and agree to comply with the study procedures.
Age from 20 to 99 years old
Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months

Exclusion Criteria:

Age < 20 years
Refuse to sign the informed consent form
Received regional anesthesia and general anesthesia within one month
Previous cancer history
Autoimmune diseases
Chronic inflammatory diseases
Diagnosed with colorectal polyps or adenomas
Acute inflammatory or infectious diseases in three months
Other diseases decided by PI

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

PSA 4.00- 10.99 ng/ml patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joy Chang	Contact	+886-2-26558455	404	joy@cellmaxlife.com

Overall Officials

Name	Affiliation	Role
Ying-Hsu Chang	Chang Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Linkou Chang Gung Memorial Hospital	Recruiting	Taoyuan City			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided