Clinical trial · Observational
Validation of a Quality of Life Metric "Prolac-10"
Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
NCT04106531CI-TRIAL-00098480Prolac-10terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator leaving institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
| Prolactinoma | Lactotroph Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Prolactinoma Macroadenoma | — | UNRESOLVED | — |
| Prolactinoma Microadenoma | — | UNRESOLVED | — |
| Prolactin-Producing Pituitary Tumor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Validate the "Prolac-10" quality of life metric
- timeFrame
- 13-weeks post medical therapy start date
- description
- In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency.
Secondary outcomes (1)
- measure
- Validate the test-retest characteristics of the Prolac-10
- timeFrame
- 13-weeks post medical therapy start date
- description
- Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.