NCT02803697

Brief Summary

Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

June 9, 2016

Last Update Submit

October 24, 2018

Conditions

Pituitary Adenomas

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate / predictive factors of recurrence

    up to 21 years

Study Arms (1)

Patients

All patients who underwent surgery for a NFPA in Reims university hospital between 01/01/1991 and 31/12/2004

Other: Patients

Interventions

PatientsOTHER
Patients

Eligibility Criteria

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

All patients who underwent surgery for a NFPA in Reims university hospital between 01/01/1991 and 31/12/2004, at least 10 years of follow-up. One group.

You may qualify if:

  • Patients \>18 year-old
  • diagnosis of NFPAs confirmed with hormonal and histological analysis
  • patients who underwent surgery in neurosurgery unit of the Reims university hospital between 01/01/1991 and 31/12/2004

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 17, 2016

Study Start

November 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

FR(1)