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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date June 2023
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
United States Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

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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