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Investigator leaving institution
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Hardesty, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
We do not plan to share IPD
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| ID | Term |
|---|---|
| D015175 | Prolactinoma |
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D004701 |
| Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |