Sellar and Suprasellar MassesNCT04369703
Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
An observational study of Sellar and Suprasellar Masses and Pituitary Tumor, run by Mayo Clinic at 1 site in United States.
Trial summary
1. Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy. 2. Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy 3. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Sellar and Suprasellar Masses, Pituitary Tumor
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 29 Apr 2022
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sellar and suprasellar masses.
Who may be able to join
- Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester.
Who cannot join
- Patients with preexisting CDI.
Trial locations and contacts
1 site in 1 country.
About this study
- Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy.
- Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy
- Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.
Read the detailed description
Patient serum levels of copeptin would be measured after phlebotomy of 3 ml of blood in EDTA tube twice a) within 1-4 hours of extubation and b) within 4-24 hours of extubation (the morning following surgery).
- Conditions
- Sellar and Suprasellar Masses, Pituitary Tumor
- Medical subject headings
- Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict central diabetes insipidus development
Using the measured lab value, we will access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy.
Measured: 2 years
Predict lack of central diabetes insipidus development
Using the measured lab value, we will access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy
Measured: 2 years
Assess relative change
Using the measured lab value, we will access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Jan 2020
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sellar and Suprasellar MassesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Erickson, Mayo Clinic
- Investigators
- Dana Erickson, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369703
- Sponsor's protocol ID
- 19-010785
- Status last verified
- Jun 2022
- First submitted
- 2 Mar 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
- ClinicalTrials.gov ID
- NCT04369703
- Acronym / sponsor ID
- 19-010785
- Conditions
- Sellar and Suprasellar Masses, Pituitary Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 30 Apr 2020 (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.
- Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy.
- Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy
- Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.
Detailed description
Patient serum levels of copeptin would be measured after phlebotomy of 3 ml of blood in EDTA tube twice a) within 1-4 hours of extubation and b) within 4-24 hours of extubation (the morning following surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sellar and suprasellar masses.
Key inclusion criteria (1 listed)
- Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester.
Key exclusion criteria (1 listed)
- Patients with preexisting CDI.
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
Predict central diabetes insipidus development
Time frame: 2 years
Using the measured lab value, we will access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy.
Predict lack of central diabetes insipidus development
Time frame: 2 years
Using the measured lab value, we will access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy
Assess relative change
Time frame: 2 years
Using the measured lab value, we will access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.
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 3 Jun 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Sellar and Suprasellar Masses
Enrolling by invitationPhase 4
Randomized Controlled Clinical Study on the Prophylactic Intraoperative Use of Desmopressin in Complex Sellar Region Tumors
Craniopharyngiomas, Pituitary Macroadenoma
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.
Dana Erickson, M.D. principal investigator
Mayo Clinic
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 Sellar and Suprasellar Masses and Pituitary Tumor, run by Mayo Clinic 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 1 inclusion and 1 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 3 Jun 2022. 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?
Predict central diabetes insipidus development (time frame: 2 years). The study lists 3 primary outcomes in all. 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 3 Jun 2022.