Metabolomic Study for Localized Prostate Cancer | NCT01968538

Studies
Metabolomic Study for Localized Prostate Cancer

NCT01968538

Sponsor

Georgetown University

Status

Unknown status

Last Update Posted

Feb 28, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Radiation Therapy

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

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Sep 19, 2013

First Submission Date that Met QC Criteria

Oct 18, 2013

First Posted Date

Oct 24, 2013Estimated

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

Feb 27, 2023

Last Update Posted Date

Feb 28, 2023Actual

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

Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. We propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.

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

Retention

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prostate Cancer Patients		Prostate cancer patients who underwent radiation therapy	Radiation: Radiation Therapy
Healthy control		age-matched male who has no known prostate cancer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation Therapy	Radiation		Prostate Cancer Patients	Prostate stereotactic body radiation therapy (SBRT) and intensive modulated radiation therapy (IMRT) or the combination of both (boost)

Measure	Description	Time Frame
molecular changes in biofluid		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males who are older than 18 years old,
with clinically localized prostate cancer
are receiving radiation therapy

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

200 prostate cancer patients vs. 200 healthy men

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sean P Collins, MD, PhD	Georgetown University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University Hospital		Arlington	Virginia	22209	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

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy
D016634	Radiosurgery
D050397	Radiotherapy, Intensity-Modulated

Ancestor Terms

ID	Term
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided