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

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Ohio State University
Updated on 28 February 2022


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.


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.

Condition Prolactinoma, Prolactin-Producing Pituitary Tumor, Pituitary Tumor, Prolactinoma Macroadenoma, Prolactinoma Microadenoma
Clinical Study IdentifierNCT04106531
SponsorOhio State University
Last Modified on28 February 2022


Yes No Not Sure

Inclusion Criteria

Patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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