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Validation of a Quality of Life Metric "Prolac-10" (Prolac-10)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106531
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Douglas Hardesty, Ohio State University

Tracking Information
First Submitted Date September 25, 2019
First Posted Date September 27, 2019
Last Update Posted Date March 4, 2020
Actual Study Start Date October 15, 2019
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2019)
Validate the "Prolac-10" quality of life metric [ Time Frame: 13-weeks post medical therapy start date ]
In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 25, 2019)
Validate the test-retest characteristics of the Prolac-10 [ Time Frame: 13-weeks post medical therapy start date ]
Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of a Quality of Life Metric "Prolac-10"
Official Title Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
Brief Summary This is a short-term validation study of a quality of life metric "Prolac-10" for patients diagnosed with a prolactinoma, undergoing new medical therapy.
Detailed Description

This is a single-site validation study of a novel quality of life study for patients undergoing medical therapy for prolactinoma. Patients will be consented before starting their medical regimen and complete the "Prolac-10" questionnaire for baseline and will continued to be followed for 13-weeks into their medical care. The primary goal of this study is to validate the novel quality of life questionnaire in terms of sensitivity, repeatability, and consistency. Secondarily, we aim to validate the test-retest characteristics to further validate sensitivity, repeatability, and consistency.

The Prolac-10 metric is Copyright © 2019. The Ohio State University. Modification/derivative rights reserved, all other rights available.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study participants will be 18 years or older, diagnosed with a prolactinoma via appropriate laboratory testing and imaging, and will be naive to medical treatment for prolactinoma.
Condition
  • Prolactinoma
  • Prolactin-Producing Pituitary Tumor
  • Pituitary Tumor
  • Prolactinoma Macroadenoma
  • Prolactinoma Microadenoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 25, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging.
  • 18 years of age or older
  • The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent

Exclusion Criteria:

  • Patient is a prisoner
  • Patient is not English speaking
  • Patient has been previously treated for prolactinoma
  • Patient is pregnant at time of diagnosis and treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Josh Bolender, BS 614-685-8622 Joshua.Bolender@osumc.edu
Contact: Amy Minnema, MS 614-685-9827 Amy.Minnema@osumc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04106531
Other Study ID Numbers 2019H0375
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: We do not plan to share IPD
Responsible Party Douglas Hardesty, Ohio State University
Study Sponsor Ohio State University
Collaborators Not Provided
Investigators
Principal Investigator: Douglas Hardesty, MD Ohio State University
PRS Account Ohio State University
Verification Date March 2020