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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01903967
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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 or disease
Pituitary Tumors

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Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Identification of GENEtic Markers of Aggressiveness and Malignancy by Array Comparative Genomic Hybrization Analysis (CGH)
Study Start Date : September 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

"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

Primary Outcome Measures :
  1. DNA alterations associated with the prognosis of pituitary tumours. [ Time Frame: At least 5 years of follow-up ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01903967

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Hospices Civils de Lyon - Groupement Hospitalier Est
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Gérald RAVEROT, PhD - MD Hospices Civils de Lyon
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon Identifier: NCT01903967    
Other Study ID Numbers: D50834
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Keywords provided by Hospices Civils de Lyon:
CGH array
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Behavioral Symptoms