ProlactinomaProlac-10NCT04106531
Validation of a Quality of Life Metric "Prolac-10"
An observational study of Prolactinoma and Prolactin-Producing Pituitary Tumor, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolactinoma, Prolactin-Producing Pituitary Tumor, Pituitary Tumor
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 13 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
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.
Read the detailed 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.
- Conditions
- Prolactinoma, Prolactin-Producing Pituitary Tumor, Pituitary Tumor, Prolactinoma Macroadenoma, Prolactinoma Microadenoma
- Medical subject headings
- Prolactinoma, Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13-weeks post medical therapy start date
Secondary outcomes (1)
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.
Measured: 13-weeks post medical therapy start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start15 Oct 2019
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Why it stopped: Investigator leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlactinomaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Hardesty, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106531
- Sponsor's protocol ID
- 2019H0375
- Acronym
- Prolac-10
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
- ClinicalTrials.gov ID
- NCT04106531
- Acronym / sponsor ID
- Prolac-10 / 2019H0375
- Conditions
- Prolactinoma, Prolactin-Producing Pituitary Tumor, Pituitary Tumor, Prolactinoma Macroadenoma, Prolactinoma Microadenoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator leaving institution
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validate the "Prolac-10" quality of life metric
Time frame: 13-weeks post medical therapy start date
In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency.
1 secondary outcome
Validate the test-retest characteristics of the Prolac-10
Time frame: 13-weeks post medical therapy start date
Results and safety
The study was stopped early (reason given: Investigator leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. We do not plan to share IPD
Related trials for Prolactinoma
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Active, not recruitingObservational study
Long Term Outcome Study in Patients With Pituitary Disorders
Pituitary Diseases, Pituitary Neoplasms
RecruitingPhase 3
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Prolactinoma, Prolactin Excess
RecruitingPhase 2
A Study of Pasireotide in People With Prolactinoma
Prolactin-Producing Pituitary Tumor
Active, not recruitingObservational study
The PROMISE Survey
Prolactinoma, Pituitary Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Hardesty, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolactinoma and Prolactin-Producing Pituitary Tumor, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator leaving institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the "Prolac-10" quality of life metric (time frame: 13-weeks post medical therapy start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.