NCT02471157

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

May 4, 2015

Last Update Submit

January 23, 2019

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Eugonadal

Eugonadal men

Other: Observation

Hypogonadal

Hypogonadal men

Other: Observation

Interventions

ObservationOTHER
EugonadalHypogonadal

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men undergoing renal, bladder, and colorectal surgery for cancer

You may qualify if:

  • Undergoing above surgery for cancer

You may not qualify if:

  • Started hormonal replacement in past two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Hypogonadism

Interventions

Observation

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Douglas Scherr, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

June 15, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

US(1)