NCT04369703

Brief Summary

  1. 1.Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy.
  2. 2.Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy
  3. 3.Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

March 2, 2020

Last Update Submit

June 1, 2022

Conditions

Sellar and Suprasellar MassesPituitary Tumor

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    2 years

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sellar and suprasellar masses.

You may qualify if:

  • \* Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester.

You may not qualify if:

  • \* Patients with preexisting CDI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Links

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Dana Erickson, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 2, 2020

First Posted

April 30, 2020

Study Start

January 28, 2020

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)