PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon

Pituitary Tumor Clinical Trial

— PITUICARE-Lyon  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854228
• Other study ID #: 69HCL16_0506
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2016
• Last updated: July 29, 2016
• Start date: February 2007
• Est. completion date: December 2020

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: Gerald Raverot, MD PhD
• Phone: (0)472119325
• Email: gerald.raverot[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 2020
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with confirmed pituitary disease

Exclusion Criteria:

• patients who do not have confirmed pituitary disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Locations

Country	Name	City	State
France	Groupement Hospitalier Est, Lyon, France	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Correlation between percentage of SSTR expression of the pituitary tumor and somatostatine analogs efficacy.	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	No
Secondary	Correlation between percentage of MGMT expression of the pituitary tumor and tumor response to temozolomide.	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	No