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

Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance as Well as Variations and Allelic Mutations in the Main Genes Involved in the Occurrence of Age-related Myelodysplastic Syndromes

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aging
• Intervention / Treatment: Diagnostic test: dosage

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: marion causeret; Phone Number: 0492034702; Email: causeret.m@chu-nice.fr
• Study Contact Backup: Name: Andrea CICCONE; Phone Number: 0492034702; Email: ciccone.a@hu-nice.fr

Study Locations

• France
  • Nice, France, 06003
    • CHU de Nice
    • Contact: marion causeret; Phone Number: 0492034702; Email: causeret.m@chu-nice.fr
    • Contact: Andrea CICCONE; Phone Number: 0492034702; Email: ciccone.a@hu-nice.fr
    • Principal Investigator: Andrea CICCONE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: evaluation of LAMP-2 protein expression; dosing of level expression of LAMP-2	Diagnostic test: dosage; Presence of mutation on the gene panel and Frequency of allele variation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Andrea CICCONE, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 2, 2024
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23-PP-13; 2024-A00321-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No