Collecting and Storing Blood and Tumor Tissue Samples Fro... | NCT00991315

Studies
Collecting and Storing Blood and Tumor Tissue Samples From Patients Undergoing Prostatectomy or Transurethral Resection of the Prostate

NCT00991315

Sponsor

Rutgers, The State University of New Jersey

Status

Terminated

Last Update Posted

Apr 8, 2021Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
P30CA072720	U.S. NIH Grant/Contract		View source
0220080275	Other Identifier	IRB #
080809	Other Identifier	Rutgers Cancer Institute of New Jersey

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Specimens are now collected through the BRS protocol.

Expanded Access Info

Start Date

Dec 12, 2008Actual

Primary Completion Date

Apr 10, 2017Actual

Completion Date

Apr 10, 2017Actual

First Submitted Date

Oct 7, 2009

First Submission Date that Met QC Criteria

Oct 7, 2009

First Posted Date

Oct 8, 2009Estimated

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

Apr 7, 2021

Last Update Posted Date

Apr 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Isaac Yi Kim, MD, PhD, MBA, Associate Professor, Rutgers, The State University of New JerseyPrincipal Investigator

Lead Sponsor

Rutgers, The State University of New JerseyOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH
Rutgers Cancer Institute of New Jersey	OTHER

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

The primary objective of this study is to collect material for study's to assess mechanisms of tumor progression, mechanisms of resistance, isolation of stem cells and biologic markers in tissue, serum and peripheral blood mononuclear cells.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

126Actual

Measure	Description	Time Frame
Collection and freezing of tumor samples		5 years

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Undergoing routine prostatectomy or transurethral resection of the prostate (TURP)

PATIENT CHARACTERISTICS:

5.1.1 Patient is undergoing routine prostatectomy or TURP.

5.1.2 Patient is ≥ 18 years old.

5.1.3 Patient must give informed consent.

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any patient undergoing a routine prostatectomy or TURP (transurethral resection of the prostate) may be asked to participate

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isaac Kim, MD, PhD	Rutgers Cancer Institute of New Jersey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rutgers Cancer Institute of New Jersey		New Brunswick	New Jersey	08903	United States

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