PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon (PITUICARE-Lyon)

July 29, 2016 updated by: Hospices Civils de Lyon

PITUItary Carcinomas or Aggressive Tumors REgistry: Monocentric Study Form a Cohort of Patient Operated on for Pituitary Tumors in University Hospital of Lyon (France)

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

tertiary referral center

Description

Inclusion Criteria:

• patients with confirmed pituitary disease

Exclusion Criteria:

• patients who do not have confirmed pituitary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival after pituitary surgery according to the clinicopathological classification (HYPOPRONOS)
Time Frame: up to 10 years (postoperatively)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between percentage of SSTR expression of the pituitary tumor and somatostatine analogs efficacy.
Time Frame: 2007-2020

Analysis of the expression of SST receptors in GH, PRL and ACTH secreting pituitary tumors: SSTR expression accessed by immunohistochemistry of the pituitary tumor.

Evaluation of the response to somatostatine analogs: somatostatine analogs efficacy evaluated by normalization of hormone hypersecretion in ACTH, GH and PRL secreting pituitary tumor.
2007-2020
Correlation between percentage of MGMT expression of the pituitary tumor and tumor response to temozolomide.
Time Frame: 2007-2020
Evaluation of MGMT expression (accessed by immunohistochemistry of the pituitary tumor) and response to temozolomide treatment (evaluated according to RECIST criteria) for patient presenting multirecurrent tumors resistant to conventional treatment.
2007-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Gerald Raverot, MD PhD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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