NCT02854228

Brief Summary

The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.

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
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

8.8 years

First QC Date

July 27, 2016

Last Update Submit

July 29, 2016

Conditions

Keywords

Pituitary tumorpituitary carcinomaacromegalycushingprolactinoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival after pituitary surgery according to the clinicopathological classification (HYPOPRONOS)

    Clinical, biochemical et imaging evaluation of a cohort of patient operated in the referral center for pituitary tumor. Identification of recurrence or progression an analysis of the clinicopathological classification. Evaluation of the different therapeutic strategies (med, surgery, chemotherapies, radiation therapy) to prevent recurrence or tumor progression.

    up to 10 years (postoperatively)

Secondary Outcomes (2)

  • Correlation between percentage of SSTR expression of the pituitary tumor and somatostatine analogs efficacy.

    2007-2020

  • Correlation between percentage of MGMT expression of the pituitary tumor and tumor response to temozolomide.

    2007-2020

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

tertiary referral center

You may qualify if:

  • patients with confirmed pituitary disease

You may not qualify if:

  • patients who do not have confirmed pituitary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupement Hospitalier Est, Lyon, France

Bron, 69500, France

RECRUITING

Related Publications (1)

  • Raverot G, Dantony E, Beauvy J, Vasiljevic A, Mikolasek S, Borson-Chazot F, Jouanneau E, Roy P, Trouillas J. Risk of Recurrence in Pituitary Neuroendocrine Tumors: A Prospective Study Using a Five-Tiered Classification. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3368-3374. doi: 10.1210/jc.2017-00773.

Biospecimen

Retention: SAMPLES WITH DNA

DNA and pituitary tumor frozen sample (Neurobiotec Biological Resource Centre (BRC) of Hospices Civils de Lyon (HCL))

MeSH Terms

Conditions

Pituitary NeoplasmsAcromegalyProlactinoma

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 DiseasesBone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Gerald Raverot, MD PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald Raverot, MD PhD

CONTACT

Emmanuel Jouanneau, MD PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 3, 2016

Study Start

February 1, 2007

Primary Completion

December 1, 2015

Study Completion

December 1, 2020

Last Updated

August 3, 2016

Record last verified: 2016-07

Locations