NCT04860037

Brief Summary

The diagnosis and the follow-up of acromegalic patients are based on the mesurement of Growth hormone (GH) and IGF1 rates. However, the literature described some cases of patient for whom the investigators observed a discrepancy between GH and IGF1 rates. Since the acromegaly is a rare disease and this phenomenon concerns about 30% of these patients, there is a lack of investigations about consequences that this discordance may induces. In this study, the investigators aimed at assessing if patients with discordance between GH and IGF1 rates present a different risk of recurrence and complications related to acromegaly, from patients with concordant results.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2010

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

12.3 years

First QC Date

April 22, 2021

Last Update Submit

April 22, 2021

Conditions

Keywords

EndocrinologyAcromegalyDiscrepancyComplications

Outcome Measures

Primary Outcomes (1)

  • Occurrence of complications and/or recidivism related to acromegaly

    The investigators check in the patient file if there is complications or pathology recidivism detected at the last full check-up of the disease, assessed by blood-control and complementary exams

    day 1

Secondary Outcomes (1)

  • Disease's specificity

    day 1

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult acromegalic patient followed up in the Occitanie region (independent endocrinologist ou working in hospital of Montpellier, Nimes or Béziers)

You may qualify if:

  • Acromegaly followed up in one of the center (Montpellier, Nimes or Béziers hospital, independent endocrinologist) between 2010 and 2021
  • Age over 18 years old
  • Measurement of GH and IGF1 rates at the last visit control available

You may not qualify if:

  • Lost to follow-up
  • Status about complications related to acromegaly unknown

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Isabelle RAINGEARD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 26, 2021

Study Start

January 1, 2010

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations