NCT06357923

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2024Sep 2026

First Submitted

Initial submission to the registry

April 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 26, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2026

Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

April 5, 2024

Last Update Submit

September 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Expression level of LAMP2 (protein and isoform A and B mRNA)

    dosage

    day 0

Secondary Outcomes (1)

  • Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes

    day 0

Study Arms (1)

evaluation of LAMP-2 protein expression

OTHER

dosing of level expression of LAMP-2

Diagnostic Test: dosage

Interventions

dosageDIAGNOSTIC_TEST

Presence of mutation on the gene panel and Frequency of allele variation

evaluation of LAMP-2 protein expression

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 60 years of age.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Nice

Nice, 06003, France

RECRUITING

Study Officials

  • Andrea CICCONE

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea CICCONE

CONTACT

marion causeret

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 10, 2024

Study Start

September 26, 2024

Primary Completion (Estimated)

September 26, 2026

Study Completion (Estimated)

September 26, 2026

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations