Validation of a Quality of Life Metric "Prolac-10"

NCT04106531 | Terminated

• 1 other identifier: 2019H0375
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolactinoma; Prolactin-Producing Pituitary Tumor; Pituitary Tumor; Prolactinoma Macroadenoma; Prolactinoma Microadenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validate the test-retest characteristics of the Prolac-10

  13-weeks post medical therapy start date

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Prolactinoma; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Study Officials

• Douglas Hardesty, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: October 15, 2019
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)