Pituitary TumorPITUICARE-LyonNCT02854228
PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon
An observational study of Pituitary Tumor, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Tumor
- How many people
- 1,300 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: tertiary referral center
Who may be able to join
- patients with confirmed pituitary disease
Who cannot join
- patients who do not have confirmed pituitary disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupement Hospitalier Est, Lyon, France
Bron, 69500
Gerald Raverot, MD PhD, (0)472119325 ext. +33, gerald.raverot@chu-lyon.fr
Emmanuel Jouanneau, MD PhD, (0)472357411 ext. +33, emmanuel.jouanneau@chu-lyon.fr
About this study
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)
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.
- Conditions
- Pituitary Tumor
- Keywords
- Pituitary tumor, pituitary carcinoma, acromegaly, cushing, prolactinoma
- Medical subject headings
- Pituitary Neoplasms, Acromegaly, Prolactinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 years (postoperatively)
Secondary outcomes (2)
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.
Measured: 2007-2020
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.
Measured: 2007-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startFeb 2007
- Primary completionDec 2015
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Raverot, MD PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854228
- Sponsor's protocol ID
- 69HCL16_0506
- Acronym
- PITUICARE-Lyon
- Status last verified
- Jul 2016
- First submitted
- 27 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Raverot G, Dantony E, Beauvy J, Vasiljevic A, Mikolasek S, Borson-Chazot F, Jouanneau E, Roy P, Trouillas J. Risk of Recurrence in Pituitary Neuroendocrine Tumors: A Prospective Study Using a Five-Tiered Classification. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3368-3374. doi: 10.1210/jc.2017-00773.
PubMed 28651368
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02854228
- Acronym / sponsor ID
- PITUICARE-Lyon / 69HCL16_0506
- Conditions
- Pituitary Tumor
- Keywords
- Pituitary tumor, pituitary carcinoma, acromegaly, cushing, prolactinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- tertiary referral center
Key inclusion criteria (1 listed)
- patients with confirmed pituitary disease
Key exclusion criteria (1 listed)
- patients who do not have confirmed pituitary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Correlation between percentage of SSTR expression of the pituitary tumor and somatostatine analogs efficacy.
Time frame: 2007-2020
Correlation between percentage of MGMT expression of the pituitary tumor and tumor response to temozolomide.
Time frame: 2007-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Derived from this study: PubMed 28651368Raverot G, Dantony E, Beauvy J, Vasiljevic A, Mikolasek S, Borson-Chazot F, Jouanneau E, Roy P, Trouillas J. Risk of Recurrence in Pituitary Neuroendocrine Tumors: A Prospective Study Using a Five-Tiered Classification. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3368-3374. doi: 10.1210/jc.2017-00773.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Raverot, MD PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Tumor, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerald Raverot, MD PhD ((0)472119325 ext. +33, gerald.raverot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival after pituitary surgery according to the clinicopathological classification (HYPOPRONOS) (time frame: up to 10 years (postoperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.