- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02903277
National Observatory of Chronic Myeloid Leukemia Adolescent and Young Adults Treated With Tyrosine Kinase Inhibitors in First Intent
12 settembre 2016 aggiornato da: Centre Hospitalier Universitaire de Nice
The median age of onset of chronic myeloid leukemia (CML) in chronic phase PC is about 60 years.
However CML affects all age groups including 18-25 year olds, called adult-young adolescents (AJA).
In France, there is no record of CML and especially not for this particular population, only a European Register of CML in children up to 18 years has been set up under the coordination of Professor "Frederic Millot", pediatrics, CHU Poitiers.
Malignancies diagnosed in this population usually have characteristics, evolution, therapeutic strategies with tyrosine kinase inhibitors (TKIs) are a real therapeutic revolution with an overall survival very significantly augmented but at present only a minority of patients may one day consider a final judgment of treatment.
AJA are the most exposed patients to the complications, the socio-economic repercussions, professional and personal of a very long-term treatment.
But there is little data in the literature concerning this population.
Two studies show that diagnosis of CML presents with poor prognostic factors (high skoal), the observed responses are poorer compared to older patients but it is accompanied difference in survival in all cases with a decline of about 70 mois.
However, these studies have focused solely on the patients included in the study receiving optimized treatment is not the standard treatment at the time.
It is clearly demonstrated that the inclusion in a study brings a benefit to the patient.
However, the majority of AJA are not included in a study.
The investigators therefore want to describe the AYA population of CML in France and compare the evolution of patients included or not in a protocol.
The investigators also want to investigate specific issues of the age of these patients as the reproductive desire.
Indeed, while it does not seem to be any risk of teratogenicity for men treated with ITK, this risk is clearly established for women and requires specific supported.
Another important point is that of the quality of life.
The state of physical and mental health and his feelings, physical activity and its limitations and well-being was assessed by the SF-3612 questionnaire.
The results of this analysis were compared with those already obtained for the general population (not representative of Italian adults with cancer sample) and adjusted for sex, age, geographic region, marital status and education level .
There seems to be young people and women who express a feeling more pejorative.
This does not only covers the frequency of side effects but also on physical activity and well-being.
the affected population will be noted that that is particularly involved in the social, professional and in the development of his personal life.
The impact of treatment on quality of life must be considered under penalty of seeing the difficulties of compliance.
But several studies have demonstrated the negative impact of poor adherence in response to treatments .
Panoramica dello studio
Stato
Sconosciuto
Tipo di studio
Osservativo
Iscrizione (Anticipato)
150
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 30 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
All patients aged 18 to 30 years diagnosed with CML treated with a frontline ITK will be included in the observatory after collecting their non-opposition.
In the retrospective part of the study, we will collect data from dead or lost to patients.
Descrizione
Inclusion Criteria:
- patients aged 18 to 30 years
- patients diagnosed with CML treated with TKI first line
- collecting their non-opposition
Exclusion Criteria:
- none
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Collect clinical data of diagnosis of the AJA CML patients
Lasso di tempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Treatment choices of the AJA CML patients
Lasso di tempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Tolerance of treatments
Lasso di tempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Adherence to therapeutic response
Lasso di tempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Evolution of the disease
Lasso di tempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Survival of the patient
Lasso di tempo: Change from the inclusion at modification of treatment
|
Describe the characteristics of the AJA CML patients (18-30 years) in terms of presentation at diagnosis, treatment choices, tolerance, adherence to therapeutic response, evolution and survival.
|
Change from the inclusion at modification of treatment
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2016
Completamento primario (Anticipato)
1 novembre 2016
Completamento dello studio (Anticipato)
1 novembre 2021
Date di iscrizione allo studio
Primo inviato
21 luglio 2016
Primo inviato che soddisfa i criteri di controllo qualità
12 settembre 2016
Primo Inserito (Stima)
16 settembre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
16 settembre 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 settembre 2016
Ultimo verificato
1 agosto 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14-PP-10
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .