- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02751827
Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer (PreToxE)
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Bordeaux, Frankrig, 33076
- Institut Bergonie
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Lyon Cedex 08, Frankrig, 69373
- Centre Léon Berard
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major.
All eligible patients who have received at least one TKI administration were included in analysis.
Beskrivelse
Inclusion Criteria:
- Age ≥ 70 years
- Treatment with pazopanib, regorafenib, sorafenib, sunitinib,axitinib in the context of market authorization
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Exclusion Criteria:
- Patient treated in a context of clinical trial
- Patient with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Prospective cohort
Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major. All eligible patients who have received at least one TKI administration were included in analysis. |
One blood sample before treatment initiation (Cycle 1 Day predose) for pharmacogenomics One blood sample at the end of the firth month of treatment (postdose) for pharmacokinetic |
Retrospective cohort A
Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major. All eligible patients who have received at least one TKI administration were included in analysis. |
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Retrospective cohort B
Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major. All eligible patients who have received at least one TKI administration were included in analysis. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Rate of Severe Toxicity
Tidsramme: During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.
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Severe toxicity was defined as any TKI-related adverse events (AE) leading to any one of the following events: death, persistent or significant disability/incapacity (defined as a permanent physical or mental impairmentwhich seriously limits one or more functional capacities such as mobility, communication, self-care, self-direction, or interpersonal skills), unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. All adverse events (AE) were graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0). |
During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IB 2015-02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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