A Research Registry on Aggressive PitNETs | NCT05974696

Studies
A Research Registry on Aggressive PitNETs

NCT05974696

Sponsor

Hospices Civils de Lyon

Status

Recruiting

Last Update Posted

Aug 8, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Endocrine Tumor

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2023Actual

Primary Completion Date

Jun 15, 2029Estimated

Completion Date

Jun 15, 2029Estimated

First Submitted Date

Jul 26, 2023

First Submission Date that Met QC Criteria

Jul 26, 2023

First Posted Date

Aug 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2023

Last Update Posted Date

Aug 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients RECAPitNETT		All adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterisation of aggressiveness of pituitary tumours by tanscriptome analysis	Molecular and transcriptomic signature of aggressiveness of pituitary tumours predictive of prognosis	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :
- Patients with a diagnosis of pituitary tumour
- Patients whose file has been presented to the national HYPOcare RCP
Exclusion Criteria :
- Patients objecting to participating in this research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon - Groupement Hospitalier Est	Recruiting	Lyon		69003	France

Condition Browse Module

MeSH Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D035583	Rare Diseases

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D004700	Endocrine System Diseases
D020969	Disease Attributes

Browse Leaves

Not provided

Browse Branches

Not provided