Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hormonal Predictors of Oncologic Surgery (HPOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471157
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment
Hypogonadism Other: Observation

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Association of Hypogonadism and Post-operative Outcomes of Oncologic Surgery
Study Start Date : January 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Group/Cohort Intervention/treatment
Eugonadal
Eugonadal men
Other: Observation
Hypogonadal
Hypogonadal men
Other: Observation



Primary Outcome Measures :
  1. Length of Stay [ Time Frame: 6 days, on average ]
    Length of post-operative stay

  2. Complication rate, post-operative [ Time Frame: 6 days, on average ]
    Complication rate during initial postoperative period

  3. Complication rate, 30 day [ Time Frame: 30 days ]
    Complication rate during the initial 30 days after surgery

  4. Complication rate, 90 days [ Time Frame: 90 days ]
    Complication rate during the initial 90 days after surgery


Biospecimen Retention:   Samples Without DNA
Serum samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men undergoing renal, bladder, and colorectal surgery for cancer
Criteria

Inclusion Criteria:

  • Undergoing above surgery for cancer

Exclusion Criteria:

  • Started hormonal replacement in past two months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471157


Locations
Layout table for location information
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Douglas Scherr, MD Weill Medical College of Cornell University
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02471157    
Other Study ID Numbers: 1408015434
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypogonadism
Gonadal Disorders
Endocrine System Diseases