- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07914972
Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients (iTERESA)
iTERESA Study Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients.
The iTERESA study is a retrospective, cross-sectional, non interventional, multi-country observational HCPs survey designed to characterize real-world management of adult patients with stage I-II unresected NSCLC.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: AstraZeneca Clinical Study Information Center
- Telefonní číslo: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC.
Popis
Inclusion Criteria:
- - Patient with unresected stage I-II NSCLC
- - Patient aged 18 years or older at the time of diagnosis
Exclusion Criteria:
- - Patients with anaplastic lymphoma kinase mutation (ALK)
- - Patients with previous history of cancer
- - Patients without post-diagnosis information
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: OTHER
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
|
Adult patients with stage I-II unresected NSCLC
The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Description of real-world treatment patterns in adult patients with stage I-II unresected NSCLC as per HCP practice.
Časové okno: 3 months
|
The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Type of RT administered, Intent of RT, Timing of RT relative to diagnosis, Managing approach following RT and use of systemic therapy, Type of systemic therapy following RT, Timing of systemic therapy following RT, RT interruption, Reasons for RT interruption). |
3 months
|
|
Description of real-world clinical outcomes in adult patients with stage I-II unresected NSCLC as per HCP practice.
Časové okno: 3 months
|
The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Disease status after treatment, specifically evaluating proportion of patients remaining disease-free over time and NSCLC-related mortality over time. Timing between treatment and outcomes of interest, specifically evaluating proportion of patients experiencing disease recurrence over time and distribution of first recurrence type (local, regional, and distant) o Time-to-recurrence distribution by recurrence type. |
3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Description of patient-level treatment patterns in adult patients with stage I-II unresected NSCLC as per patient reported form (PRF) - based on HCPs' recall.
Časové okno: 3 months
|
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Type of RT received, Intent of RT, Timing of RT relative to diagnosis, Performance of confirmatory biopsy prior to RT initiation, Systemic therapy following RT, Timing of systemic therapy following RT, RT interruption, Reasons for RT interruption) |
3 months
|
|
Description of patient-level clinical outcomes in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.
Časové okno: 3 months
|
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Occurrence and type of treatment-related side effects during or after RT, Disease status after treatment, Most recent disease status after treatment completion, Timing between RT and outcomes of interest). |
3 months
|
|
Description of patient-level demographic of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.
Časové okno: 3 Months
|
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Age class, sex, race). |
3 Months
|
|
Description of patient-level clinical characteristics of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.
Časové okno: 3 months
|
The description will be based on patient-level information collected through the Patient Report Forms based on HCPs' recall (Stage of NSCLC, TNM staging (excluding the M component), Histology, Eastern Cooperative Oncology Group (ECOG) performance status, Tumor location (central versus peripheral), Reason for non-resection, Specialist responsible for determining unresectability/non operability). |
3 months
|
|
Description of patient-level molecular testing patterns in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.
Časové okno: 3 months
|
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Performance of EGFR test. Type of EGFR, Performance of PD-L1 test, PD-L1 expression status). |
3 months
|
|
Description of factors influencing treatment choice in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.
Časové okno: 3 months
|
The description will be based on patient-level information collected through the Patient Report Forms based on HCPs' recall (Factors influencing the decision not to perform surgical resection, Specialist responsible for determining unresectability/non operability, Factors determining high-risk features definition, Factors determining initial RT treatment choice, separately by treatment (SBRT/SABR and CFRT), Performance of confirmatory biopsy prior to RT initiation, separately by treatment. (SBRT/SABR and CFRT), Factors determining the choice of administering/non-administering systemic therapy after RT, Influence of EGFR results on treatment choice, Influence of PD-L1 results on treatment choice). |
3 months
|
|
Description of molecular testing pattern in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.
Časové okno: 3 months
|
The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Frequency of performance of EGFR test, EGFR type frequency, Different barriers to EGFR testing, Frequency of performance of PD-L1 test, PD-L1 status frequency, Different barriers to PD-L1 testing). |
3 months
|
|
Description of Health Care Professionals perception towards the administration of systemic therapy following RT to adult patients with stage I-II unresected NSCLC.
Časové okno: 3 months
|
The description will be based on information related to Health Care Pprofessionalss perception and practice (Strength of rationale for administering systemic therapy after RT, Barriers to systemic therapy use, Likelihood of prescription of systemic therapy, Category of patients who might benefit the most from systemic therapy according to systemic therapy type). |
3 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- D133FR00271
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Časový rámec sdílení IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Kritéria přístupu pro sdílení IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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