Study of the Evolution of the Expression of the LAMP-2 Pr... | NCT06357923

Studies
Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age

NCT06357923

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Recruiting

Last Update Posted

Sep 27, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Aging

Interventions

dosage

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

ID	Type	Description	Link
2024-A00321-46	Other Identifier	ANSM

Status Module

Record Verification Date

Sep 2024

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

Sep 26, 2024Actual

Primary Completion Date

Sep 26, 2026Estimated

Completion Date

Sep 26, 2026Estimated

First Submitted Date

Apr 5, 2024

First Submission Date that Met QC Criteria

Apr 9, 2024

First Posted Date

Apr 10, 2024Actual

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

Sep 26, 2024

Last Update Posted Date

Sep 27, 2024Actual

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

Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects > 60 years of age respecting a male/female ratio = 1.

Detailed Description

Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects > 60 years of age respecting a male/female ratio = 1. After explanations and collection consent, collection of the patient's socio-demographic and medical characteristics and then carrying out a Peripheral venous blood sample (2 x 5ml tubes).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
evaluation of LAMP-2 protein expression	Other	dosing of level expression of LAMP-2	Diagnostic Test: dosage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dosage	Diagnostic Test	Presence of mutation on the gene panel and Frequency of allele variation	evaluation of LAMP-2 protein expression

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression level of LAMP2 (protein and isoform A and B mRNA)	dosage	day 0

Secondary Outcomes

Measure	Description	Time Frame
Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes	dosage	day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women over 60 years of age.

Exclusion Criteria:

Inability to Understand Consent,
Non-Security Beneficiaries
social, subjects protected by law, subjects deprived of liberty,
history of breast cancer,
brain tumor,
melanoma,
colon cancer,
lung cancer,
prostate cancer,
lymphoma,
myeloma,
syndrome myelodysplastic/myeloproliferative,
leukemia,
history of radiation therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea CICCONE	Contact	0492034702		ciccone.a@hu-nice.fr
marion causeret	Contact	0492034702		causeret.m@chu-nice.fr

Overall Officials

Name	Affiliation	Role
Andrea CICCONE	Centre Hospitalier Universitaire de Nice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu de Nice	Recruiting	Nice		06003	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided