PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon

• Conditions: Pituitary Tumor

• Registration Number: NCT02854228
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

• patients with confirmed pituitary disease

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Exclusion Criteria

• patients who do not have confirmed pituitary disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival after pituitary surgery according to the clinicopathological classification (HYPOPRONOS)	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between percentage of SSTR expression of the pituitary tumor and somatostatine analogs efficacy.	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.
Correlation between percentage of MGMT expression of the pituitary tumor and tumor response to temozolomide.	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.

Trial Locations

Locations (1)

Groupement Hospitalier Est, Lyon, France; 🇫🇷 Bron, France