AgingNCT06357923
Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age
A study testing dosage in people with Aging, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Aging
- What is being tested?
- dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2024to 26 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 60 years of age.
Who cannot join
- Inability to Understand Consent,
- Non-Security Beneficiaries
- social, subjects protected by law, subjects deprived of liberty,
- history of breast cancer,
- brain tumor,
- melanoma,
Show all 14Show fewer
- colon cancer,
- lung cancer,
- prostate cancer,
- lymphoma,
- myeloma,
- syndrome myelodysplastic/myeloproliferative,
- leukemia,
- history of radiation therapy.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu de Nice
Nice, 06003
Andrea CICCONE, 0492034702, ciccone.a@hu-nice.fr
marion causeret, 0492034702, causeret.m@chu-nice.fr
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging
- Being tested
- dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosageDiagnostic test
Presence of mutation on the gene panel and Frequency of allele variation
| Study group | Role | What they receive |
|---|---|---|
| evaluation of LAMP-2 protein expression | Other | dosing of level expression of LAMP-2 Receives: Diagnostic Test: dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression level of LAMP2 (protein and isoform A and B mRNA)
dosage
Measured: day 0
Secondary outcomes (1)
Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes
dosage
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start26 Sep 2024
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea CICCONE, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357923
- Sponsor's protocol ID
- 23-PP-13
- Other IDs
- 2024-A00321-46
- Status last verified
- Sep 2024
- First submitted
- 5 Apr 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06357923
- Acronym / sponsor ID
- 23-PP-13
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 10 Apr 2024 (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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluation of LAMP-2 protein expression | Other | Diagnostic Test: dosagedosing of level expression of LAMP-2 |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women over 60 years of age.
Key exclusion criteria (14 listed)
- Inability to Understand Consent,
- Non-Security Beneficiaries
- social, subjects protected by law, subjects deprived of liberty,
- history of breast cancer,
- brain tumor,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dosagePresence of mutation on the gene panel and Frequency of allele variation | Diagnostic test | evaluation of LAMP-2 protein expression |
Primary outcome
Expression level of LAMP2 (protein and isoform A and B mRNA)
Time frame: day 0
dosage
1 secondary outcome
Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andrea CICCONE principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dosage in people with Aging, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea CICCONE (0492034702, ciccone.a@hu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression level of LAMP2 (protein and isoform A and B mRNA) (time frame: day 0). 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 27 Sep 2024.