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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

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.

Condition or disease
Prolactinoma Prolactin-Producing Pituitary Tumor Pituitary Tumor Prolactinoma Macroadenoma Prolactinoma Microadenoma

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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): NCT04106531


Contacts
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Contact: Josh Bolender, BS 614-685-8622 Joshua.Bolender@osumc.edu
Contact: Amy Minnema, MS 614-685-9827 Amy.Minnema@osumc.edu

Locations
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United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Joshua Bolender, BS    614-685-8622    Joshua.Bolender@osumc.edu   
Contact: Amy Minnema, MS       Amy.Minnema@osumc.edu   
Principal Investigator: Douglas Hardesty, MD         
Sub-Investigator: Daniel Prevedello, MD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Douglas Hardesty, MD Ohio State University
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Responsible Party: Douglas Hardesty, Assistant Professor, Neurological Surgery, Ohio State University
ClinicalTrials.gov Identifier: NCT04106531    
Other Study ID Numbers: 2019H0375
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pituitary Neoplasms
Neoplasms
Central Nervous System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Prolactinoma
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma