Pituitary AdenomaPAPSNCT01556230
Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
An observational study of Pituitary Adenoma and Pituitary Tumor, run by Columbia University at 1 site in United States.
Trial summary
This project is the first comprehensive prospective study of clinically non-functioning pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of 100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and do not require surgery; Group II will consist… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma, Pituitary Tumor
- What is being tested?
- Surgical intervention for CNFA and Radiotherapy for CNFA
- Type of treatment
- Surgery or procedure
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2024
- 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: Any persons diagnosed with a non-functioning pituitary adenoma that is willing to travel to our study center at Columbia University in New York for all study visits.
Who may be able to join
- adult patients with pituitary lesions that do not require surgical intervention.
- pituitary lesion that has been demonstrated on a magnetic resonance imaging (MRI) to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst).
- patients with macroadenomas (> 1 cm) or large microadenomas 6-9 mm.
- a prolactin level < 40 ng/ml.
- adult patients with pituitary lesions that require surgical intervention and are planning on surgery or who had surgery in the past and are now undergoing pituitary radiotherapy.
- pre-surgery patients will have a pituitary lesion that has been demonstrated on a MRI to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst) and that is a macroadenoma (> 1 cm).
Show all 10Show fewer
- presence of visual or neurological deficits due to the tumor or impingement of the tumor on the optic chiasm is permitted.
- a prolactin level < 100 ng/ml if lesion is > or = 10 mm in size or a prolactin level < 40 ng/ml if lesion is < 10 mm in size.
- patients with mild/moderate hyperprolactinemia and recommended for dopamine agonist therapy (on the chance that the lesion is truly a prolactinoma) may re-enter the study should they be a dopamine agonist failure and require surgery.
- patients with hypopituitarism and no other surgical indication that choose to undergo surgery is permitted.
Who cannot join
- presence of visual or neurological deficits due to the tumor, tumor impingement on the optic chiasm and physical or laboratory abnormalities consistent with a biologically active hormone secreting tumor.
- GROUP II
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Vagelos College of Physicians & Surgeons
New York, New York, 10032
About this study
This project is the first comprehensive prospective study of clinically non-functioning pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of 100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and do not require surgery; Group II will consist of 250 patients who have pituitary lesions that are symptomatic and require surgery. Patients will be followed with a series of endocrine laboratory testing, physical examinations, testing of quality of life and neurocognitive function before and serially over time either during non-surgical management or after surgery and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance imaging (MRI) studies and visual field testing being done over time during follow up as part of clinical care will be collected.
Read the detailed description
PROTOCOL I: Prospective Study of the outcome of conservative non-surgical management of patients with asymptomatic, clinically non-functioning (CNF) pituitary lesions. This protocol will evaluate prospectively the outcome of non-surgical management of clinically non-functioning pituitary lesions that do not appear to need surgery as their initial therapy. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time for up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients.
PROTOCOL II : Prospective study of the outcome of patients with symptomatic, clinically non-functioning pituitary tumors who are treated with transsphenoidal surgery and in some cases also radiotherapy. This protocol will evaluate prospectively the outcome of surgical management of asymptomatic clinically nonfunctioning pituitary lesions. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time with up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will also be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients. Data will be analyzed to determine the safety of observation alone following surgery for patients who do not have a clinically significant tumor remnant, if the silent corticotroph tumor type is characterized by elevated plasma levels of ACTH or its precursor, POMC, and if it is associated with an increased tumor recurrence rate. A group of patients who are planning RT will also be studied by these same procedures before and after RT in order to determine if the outcomes of patients who receive RT for treatment of tumor re-growth to that of those who do not receive RT with respect to further tumor growth, endocrine or neurological dysfunction. Quality of life and neurocognitive function in patients with clinically non-functioning pituitary lesions treated with surgery alone or those who also receive radiotherapy will be prospectively assessed.
- Conditions
- Pituitary Adenoma, Pituitary Tumor
- Being tested
- Surgical intervention for CNFA, Radiotherapy for CNFA
- Keywords
- pituitary gland, pituitary adenoma, pituitary tumor, hypophysis, endocrine, neuroendocrine, hormone
- Medical subject headings
- Pituitary Neoplasms, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical intervention for CNFAProcedure or surgery
(non-experimental) standard procedure
Radiotherapy for CNFARadiation
(non-experimental) standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Group I | The first group of subjects, Group I, will be followed in Protocol I and are a group of subjects with an apparent clinically nonfunctioning pituitary lesion who will be studied in a prospective study of conservative non-surgical management. | |
| Group II | A second group of subjects, Group II, are subjects who are undergoing surgical intervention for CNFA or radiotherapy for CNFA and these subjects will be studied in a prospectively follow up as part of Protocol II. Receives: Procedure: Surgical intervention for CNFA; Radiation: Radiotherapy for CNFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with pituitary tumor enlargement
Tumor enlargement over the study period
Measured: 5 years
Secondary outcomes (1)
Change in neurocognitive function test score
Neurocognitive function change over the time frame of the study
Measured: Baseline, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startNov 2010
- Primary completionJun 2024
- Study completionJun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Columbia 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
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Pamela U. Freda, Columbia University
- Investigators
- Pamela U. Freda, MD, Principal investigator, Columbia University College of Physicians&Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556230
- Sponsor's protocol ID
- AAAE1260
- Other IDs
- R01NS070600
- Acronym
- PAPS
- Status last verified
- Jun 2024
- First submitted
- 9 Mar 2012
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT01556230
- Acronym / sponsor ID
- PAPS / AAAE1260
- Conditions
- Pituitary Adenoma, Pituitary Tumor
- Keywords
- pituitary gland, pituitary adenoma, pituitary tumor, hypophysis, endocrine, neuroendocrine, hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 2010 (actual)
- Primary completion
- Jun 2024 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 16 Mar 2012 (estimated)
- 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 project is the first comprehensive prospective study of clinically non-functioning pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of 100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and do not require surgery; Group II will consist of 250 patients who have pituitary lesions that are symptomatic and require surgery. Patients will be followed with a series of endocrine laboratory testing, physical examinations, testing of quality of life and neurocognitive function before and serially over time either during non-surgical management or after surgery and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance imaging (MRI) studies and visual field testing being done over time during follow up as part of clinical care will be collected.
Detailed description
PROTOCOL I: Prospective Study of the outcome of conservative non-surgical management of patients with asymptomatic, clinically non-functioning (CNF) pituitary lesions. This protocol will evaluate prospectively the outcome of non-surgical management of clinically non-functioning pituitary lesions that do not appear to need surgery as their initial therapy. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time for up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients.
PROTOCOL II : Prospective study of the outcome of patients with symptomatic, clinically non-functioning pituitary tumors who are treated with transsphenoidal surgery and in some cases also radiotherapy. This protocol will evaluate prospectively the outcome of surgical management of asymptomatic clinically nonfunctioning pituitary lesions. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time with up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will also be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients. Data will be analyzed to determine the safety of observation alone following surgery for patients who do not have a clinically significant tumor remnant, if the silent corticotroph tumor type is characterized by elevated plasma levels of ACTH or its precursor, POMC, and if it is associated with an increased tumor recurrence rate. A group of patients who are planning RT will also be studied by these same procedures before and after RT in order to determine if the outcomes of patients who receive RT for treatment of tumor re-growth to that of those who do not receive RT with respect to further tumor growth, endocrine or neurological dysfunction. Quality of life and neurocognitive function in patients with clinically non-functioning pituitary lesions treated with surgery alone or those who also receive radiotherapy will be prospectively assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –The first group of subjects, Group I, will be followed in Protocol I and are a group of subjects with an apparent clinically nonfunctioning pituitary lesion who will be studied in a prospective study of conservative non-surgical management. |
| Group II | – | Procedure: Surgical intervention for CNFA, Radiation: Radiotherapy for CNFAA second group of subjects, Group II, are subjects who are undergoing surgical intervention for CNFA or radiotherapy for CNFA and these subjects will be studied in a prospectively follow up as part of Protocol II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any persons diagnosed with a non-functioning pituitary adenoma that is willing to travel to our study center at Columbia University in New York for all study visits.
Key inclusion criteria (10 listed)
- adult patients with pituitary lesions that do not require surgical intervention.
- pituitary lesion that has been demonstrated on a magnetic resonance imaging (MRI) to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst).
- patients with macroadenomas (> 1 cm) or large microadenomas 6-9 mm.
- a prolactin level < 40 ng/ml.
- adult patients with pituitary lesions that require surgical intervention and are planning on surgery or who had surgery in the past and are now undergoing pituitary radiotherapy.
Key exclusion criteria (2 listed)
- presence of visual or neurological deficits due to the tumor, tumor impingement on the optic chiasm and physical or laboratory abnormalities consistent with a biologically active hormone secreting tumor.
- GROUP II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical intervention for CNFA(non-experimental) standard procedure | Procedure or surgery | Group II |
| Radiotherapy for CNFA(non-experimental) standard procedure | Radiation | Group II |
Primary outcome
Number of patients with pituitary tumor enlargement
Time frame: 5 years
Tumor enlargement over the study period
1 secondary outcome
Change in neurocognitive function test score
Time frame: Baseline, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
Pituitary Neoplasm
Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
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.
Pamela U. Freda, MD principal investigator
Columbia University College of Physicians&Surgeons
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 Pituitary Adenoma and Pituitary Tumor, run by Columbia 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 10 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jun 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with pituitary tumor enlargement (time frame: 5 years). 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 25 Jun 2024.