Pituitary Tumor Clinical Trial
— Prolac-10Official title:
Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
NCT number | NCT04106531 |
Other study ID # | 2019H0375 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | October 15, 2019 |
Est. completion date | June 13, 2023 |
Verified date | June 2023 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | June 13, 2023 |
Est. primary completion date | June 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 13-weeks post medical therapy start date | |
Secondary | 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. | 13-weeks post medical therapy start date |
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