- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02903277
National Observatory of Chronic Myeloid Leukemia Adolescent and Young Adults Treated With Tyrosine Kinase Inhibitors in First Intent
12. september 2016 oppdatert 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 .
Studieoversikt
Status
Ukjent
Studietype
Observasjonsmessig
Registrering (Forventet)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 30 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Collect clinical data of diagnosis of the AJA CML patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2016
Primær fullføring (Forventet)
1. november 2016
Studiet fullført (Forventet)
1. november 2021
Datoer for studieregistrering
Først innsendt
21. juli 2016
Først innsendt som oppfylte QC-kriteriene
12. september 2016
Først lagt ut (Anslag)
16. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. september 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. september 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-PP-10
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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