Trial record 11 of 148 for:    pituitary tumor

Identification of GENEtic Markers of Aggressiveness and Malignancy by Array Comparative Genomic Hybrization Analysis (CGH) (PITUIGENE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01903967
First received: July 17, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

Recent studies estimate that the prevalence of pituitary adenomas is approximately 1/1500 persons. Pituitary tumours are usually considered as benign. However, local invasion is reported in 35-40% of pituitary adenomas; resistance to medical treatment or recurrence leading to multimodal therapy is reported in about 15% of cases. These tumours are considered as aggressive pituitary tumours and present a distinct biological and clinical entity with continued growth despite multimodal therapy, including surgery and radiotherapy (McCormack et al., 2011). Whilst these tumours have malignant potential, the term of pituitary carcinoma is strictly reserved for those rare tumours (0.2%) with demonstrated craniospinal or systemic metastases (Heaney, 2011).

Pituitary aggressive and malignant tumours are very difficult to control and ultimately prove to be lethal. It was suggested that early aggressive treatments (chemotherapy, radiotherapy) may control progression and occurrence of metastases. However, these therapeutic options are associated with important side effects limiting their use and the prediction of pituitary tumor behaviour remains a challenge. At the diagnosis, clinical signs are not specific and the results concerning proliferative factors (Ki-67 and P53), putative oncogenes (PTTG) conflict from one series to another.

In a case-control retrospective study of a cohort of 410 patients (HYPOPRONOS), we validated a prognostic pathological classification based on histological and radiological data (J. Trouillas 2012 in preparation). Tumours were classified into 3 grades: grade 1= non-invasive tumour, grade 2= invasive tumour and grade 3 = aggressive-invasive tumor with the combination of radiological signs of invasion and 2 of 3 signs of increased proliferation (Ki-67 index>3%, number of mitoses>2 per 10 fields at 400X, P53 nuclear detection).

It is now widely accepted that cancer is a clonal disease, which arises from a single normal cell and progresses thanks to the accumulation of DNA alterations (Sanson et al., 2011). To identify the role of these DNA alterations, we conducted array CGH analysis limited to 13 prolactin pituitary tumours, from frozen fragments, and identified allelic loss of chromosome 11 associated with aggressiveness and malignancy (Wierinckx et al., 2011).

To confirm these encouraging results we propose to conduct a study on a large series of tumours, fixed and embed, and to be correlated the results to clinical data.


Condition
Pituitary Tumors

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Identification of GENEtic Markers of Aggressiveness and Malignancy by Array Comparative Genomic Hybrization Analysis (CGH)

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • DNA alterations associated with the prognosis of pituitary tumours. [ Time Frame: At least 5 years of follow-up ] [ Designated as safety issue: No ]
    To identify and quantify the genomic DNA alterations associated with the prognosis of pituitary tumours.


Biospecimen Retention:   Samples With DNA

Pituitary tumour DNA may be extracted from frozen or paraffin-embedded tumours.


Estimated Enrollment: 240
Study Start Date: September 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
"Control" Group
Patients cured with no evidence of disease up to 5 years will be the controls.
"Case" Group
Patients, in recurrence or progression before 5 years will be the cases

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting a pituitary tumour, including PRL, GH, ACTH and LH/FSH, operated on by transsphenoidal route between 1990 and 2008 with at least 5 years of follow-up

Criteria

Inclusion Criteria:

  • Only patient with complete clinical, radiological and hormonal data available during yearly follow-up will be included.
  • Preoperative MRI will be used to classify the tumour as invasive, and postoperative MRI will be collected to confirm recurrence or progression of the tumour.
  • Presence of tumour fragments fixed in Holland-Bouin's fluid or Neutral Buffered Formalin fixative available for aCGH analysis.

Exclusion Criteria:

  • Patient who underwent systematic post-operative radiotherapy.
  • Patient presenting Multiple Endocrine Neoplasia type 1 (MEN1) or aryl hydrocarbon receptor interacting protein (AIP) mutation since mechanism of tumorigenesis are different to sporadic pituitary tumours.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903967

Contacts
Contact: Gérald RAVEROT, PhD - MD 4 72 11 93 25 ext +33 gerald.raverot@chu-lyon.fr
Contact: Laurent VILLENEUVE 4 78 86 45 36 ext +33 laurent.villeneuve@chu-lyon.fr

Locations
France
Hospices Civils de Lyon - Groupement Hospitalier Est Recruiting
Lyon, France, 69003
Contact: Gérald RAVEROT, PhD - MD    4 72 11 93 25 ext +33    gerald.raverot@chu-lyon.fr   
Contact: Laurent VILLENEUVE    4 78 86 45 36 ext +33    laurent.villeneuve@chu-lyon.fr   
Principal Investigator: Gérald RAVEROT, PhD - MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Gérald RAVEROT, PhD - MD Hospices Civils de Lyon
  More Information

Additional Information:
No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01903967     History of Changes
Other Study ID Numbers: D50834
Study First Received: July 17, 2013
Last Updated: April 14, 2014
Health Authority: France: French Data Protection Authority

Keywords provided by Hospices Civils de Lyon:
Pituitary
CGH array
Tumor

Additional relevant MeSH terms:
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Pituitary Diseases
Aggression
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014