NCT02012127

Brief Summary

The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
648

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

25 active sites

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

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

November 28, 2013

Last Update Submit

August 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Description of the most characteristic sign-and-symptom associations of acromegaly, collected by a patient questionnaire.

    At the time of patient diagnosis, up to 3 months

Secondary Outcomes (1)

  • Description of demographic and clinical characteristics of patients with acromegaly, collected by a patient questionnaire.

    At the time of patient diagnosis, up to 3 months

Study Arms (1)

Acromegalic patients

Eligibility Criteria

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

Acromegalic patients

You may qualify if:

  • Adult patient (greater than or equal to 18 years old)
  • Patient with acromegaly, diagnosed for less than 5 years

You may not qualify if:

  • Patient who have objected to the collection of his/her data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Hôpital Sud

Amiens, France

Location

CHU Besançon Hôpital Jean Minjoz

Besançon, France

Location

Hôpital la Cavale Blanche

Brest, France

Location

Chu Cote de Nacre

Caen, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Chu de Grenoble Hôpital Albert Michallon

Grenoble, France

Location

Hôpital Claude Huriez

Lille, France

Location

Hôpital le Cluzeau

Limoges, France

Location

Hôpital Neuro-cardiologique

Lyon, France

Location

Hôpital de la Timone

Marseille, France

Location

Hôpital Lepeyronie

Montpellier, France

Location

Hôpitaux de Brabois

Nancy, France

Location

CHR Orléans - Hôpital la Source

Orléans, France

Location

CH de Bicetre

Paris, France

Location

CH Pitie Salpetreire

Paris, France

Location

Hôpital Lariboisiere

Paris, France

Location

Hôpital Haut Leveque

Pessac, France

Location

CHU Reims - Hôpital Robert Debre

Reims, France

Location

Hôpital Sud Anne de Bretagne

Rennes, France

Location

CHU Rouen - Hôpital de Bois Guillaume

Rouen, France

Location

Hôptital Nord

Saint-Etienne, France

Location

Hôpital Civil

Strasbourg, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

Hôpital Larrey

Toulouse, France

Location

CHU Bretonneau

Tours, France

Location

Related Publications (1)

  • Caron P, Brue T, Raverot G, Tabarin A, Cailleux A, Delemer B, Renoult PP, Houchard A, Elaraki F, Chanson P. Signs and symptoms of acromegaly at diagnosis: the physician's and the patient's perspectives in the ACRO-POLIS study. Endocrine. 2019 Jan;63(1):120-129. doi: 10.1007/s12020-018-1764-4. Epub 2018 Sep 29.

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2013

First Posted

December 16, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 5, 2019

Record last verified: 2019-08

Locations