- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02903277
National Observatory of Chronic Myeloid Leukemia Adolescent and Young Adults Treated With Tyrosine Kinase Inhibitors in First Intent
12 september 2016 uppdaterad av: 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 .
Studieöversikt
Status
Okänd
Betingelser
Studietyp
Observationell
Inskrivning (Förväntat)
150
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 30 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- patients aged 18 to 30 years
- patients diagnosed with CML treated with TKI first line
- collecting their non-opposition
Exclusion Criteria:
- none
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Collect clinical data of diagnosis of the AJA CML patients
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2016
Primärt slutförande (Förväntat)
1 november 2016
Avslutad studie (Förväntat)
1 november 2021
Studieregistreringsdatum
Först inskickad
21 juli 2016
Först inskickad som uppfyllde QC-kriterierna
12 september 2016
Första postat (Uppskatta)
16 september 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 september 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14-PP-10
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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