Hormonal Predictors of Oncologic Surgery | NCT02471157

Studies
Hormonal Predictors of Oncologic Surgery

NCT02471157

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Jan 25, 2019Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Hypogonadism

Interventions

Observation

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

May 4, 2015

First Submission Date that Met QC Criteria

Jun 10, 2015

First Posted Date

Jun 15, 2015Estimated

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 23, 2019

Last Update Posted Date

Jan 25, 2019Actual

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

An observational trial to determine whether preoperative hormonal status predicts outcomes of oncologic surgery.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eugonadal		Eugonadal men	Other: Observation
Hypogonadal		Hypogonadal men	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other		Eugonadal Hypogonadal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of Stay	Length of post-operative stay	6 days, on average
Complication rate, post-operative	Complication rate during initial postoperative period	6 days, on average
Complication rate, 30 day	Complication rate during the initial 30 days after surgery	30 days
Complication rate, 90 days	Complication rate during the initial 90 days after surgery	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing above surgery for cancer

Exclusion Criteria:

Started hormonal replacement in past two months

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men undergoing renal, bladder, and colorectal surgery for cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas Scherr, MD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medical College		New York	New York	10065	United States

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided