ProlactinomaProlac-10NCT04106531
Validation of a Quality of Life Metric "Prolac-10"
An observational study of Prolactinoma and Prolactin-Producing Pituitary Tumor, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolactinoma, Prolactin-Producing Pituitary Tumor, Pituitary Tumor
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 13 Jun 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
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.
Read the 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.
- Conditions
- Prolactinoma, Prolactin-Producing Pituitary Tumor, Pituitary Tumor, Prolactinoma Macroadenoma, Prolactinoma Microadenoma
- Medical subject headings
- Prolactinoma, Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the "Prolac-10" quality of life metric
In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency.
Measured: 13-weeks post medical therapy start date
Secondary outcomes (1)
Validate the test-retest characteristics of the Prolac-10
Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency.
Measured: 13-weeks post medical therapy start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start15 Oct 2019
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Why it stopped: Investigator leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlactinomaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Hardesty, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106531
- Sponsor's protocol ID
- 2019H0375
- Acronym
- Prolac-10
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD