Endocrine TumorRECAPitNETTNCT05974696
A Research Registry on Aggressive PitNETs
An observational study of Endocrine Tumor, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
To allow the identification of markers, it is necessary to extend research networks more widely to collect and properly explore aggressive pituitary tumours. The multidisciplinary consultation meeting (RCP), organised by the reference centre for rare diseases of the pituitary gland, dedicated to aggressive pituitary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine Tumor
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2023to 15 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group.
Who may be able to join
- Patients with a diagnosis of pituitary tumour
- Patients whose file has been presented to the national HYPOcare RCP
Who cannot join
- Patients objecting to participating in this research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Groupement Hospitalier Est
Lyon, 69003
Gérald RAVEROT, PhD - MD, 4 72 11 93 25 ext. +33, gerald.raverot@chu-lyon.fr
Laurent VILLENEUVE, 4 78 86 45 36 ext. +33, laurent.villeneuve@chu-lyon.fr
About this study
To allow the identification of markers, it is necessary to extend research networks more widely to collect and properly explore aggressive pituitary tumours. The multidisciplinary consultation meeting (RCP), organised by the reference centre for rare diseases of the pituitary gland, dedicated to aggressive pituitary tumours and carcinomas (HYPOcare), which is unique in France and brings together national experts, currently makes it possible to orientate the management of patients with an aggressive pituitary tumour. With more than 80 patient files discussed since its inception, the patient cohort via the HYPOcare RCP is one of the largest both nationally and internationally. At present, this data source is only dedicated to the clinical management of the files without the possibility of carrying out research work
- Conditions
- Endocrine Tumor
- Keywords
- Endocrine Tumor, Reference centre, rare diseases, transcriptoms
- Medical subject headings
- Endocrine Gland Neoplasms, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients RECAPitNETT | All adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of aggressiveness of pituitary tumours by tanscriptome analysis
Molecular and transcriptomic signature of aggressiveness of pituitary tumours predictive of prognosis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start15 Jun 2023
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974696
- Sponsor's protocol ID
- 69HCL23_0026
- Acronym
- RECAPitNETT
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Registry on Aggressive PitNETs
- ClinicalTrials.gov ID
- NCT05974696
- Acronym / sponsor ID
- RECAPitNETT / 69HCL23_0026
- Conditions
- Endocrine Tumor
- Keywords
- Endocrine Tumor, Reference centre, rare diseases, transcriptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 3 Aug 2023 (actual)
- 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.
To allow the identification of markers, it is necessary to extend research networks more widely to collect and properly explore aggressive pituitary tumours. The multidisciplinary consultation meeting (RCP), organised by the reference centre for rare diseases of the pituitary gland, dedicated to aggressive pituitary tumours and carcinomas (HYPOcare), which is unique in France and brings together national experts, currently makes it possible to orientate the management of patients with an aggressive pituitary tumour. With more than 80 patient files discussed since its inception, the patient cohort via the HYPOcare RCP is one of the largest both nationally and internationally. At present, this data source is only dedicated to the clinical management of the files without the possibility of carrying out research work
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients RECAPitNETT | – | –All adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group.
Key inclusion criteria (2 listed)
Key exclusion criteria (1 listed)
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
Characterisation of aggressiveness of pituitary tumours by tanscriptome analysis
Time frame: 3 years
Molecular and transcriptomic signature of aggressiveness of pituitary tumours predictive of prognosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
Related trials for Endocrine Tumor
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer
Ovary Cancer, Fallopian Tube Cancer
Recruiting
Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1
Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial
Thyroid Cancer Stage IV, Anaplastic Thyroid Cancer
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
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.
Hospices Civils de Lyon - Groupement Hospitalier Est
Lyon, France
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 Endocrine 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 2 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: looking for participants now, as of the sponsor's last update on 8 Aug 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterisation of aggressiveness of pituitary tumours by tanscriptome analysis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.