Trial Radar KI | ||
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Die klinische Studie NCT06771193 (RETRACE) für Zervixkarzinom, Lokal fortgeschrittener Gebärmutterhalskrebs, Recurrent Cervical Cancer, Metastatischer Gebärmutterhalskrebs ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy (RETRACE) 200 Beobachtend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06771193 (RETRACE) ist eine beobachtungsstudie zur Untersuchung von Zervixkarzinom, Lokal fortgeschrittener Gebärmutterhalskrebs, Recurrent Cervical Cancer, Metastatischer Gebärmutterhalskrebs und hat den Status offene rekrutierung. Die Studie startete am 17. Dezember 2024 und soll 200 Teilnehmer aufnehmen. Durchgeführt von MSD Italia S.r.l. ist der Abschluss für 1. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 20. Juli 2025 aktualisiert.
Kurzbeschreibung
Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.
Ausführliche Beschreibung
This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.
Eligible cervical cancer patients will be identified by reviewing medical records and ph...
Mehr anzeigenOffizieller Titel
RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy
Erkrankungen
ZervixkarzinomLokal fortgeschrittener GebärmutterhalskrebsRecurrent Cervical CancerMetastatischer GebärmutterhalskrebsWeitere Studien-IDs
- RETRACE
- NIS102062
NCT-Nummer
Studienbeginn (tatsächlich)
2024-12-17
Zuletzt aktualisiert
2025-07-20
Studienende (vorauss.)
2025-12
Geplante Rekrutierung
200
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%) | Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%). | Retrospective data capture from Jan 2018 to Dec 2021 |
The proportion of patient with recurrence or dead after treatment and remission (%) | Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%). | Retrospective data capture from Jan 2018 to Dec 2021 |
Median time from remission to recurrence | The study aim is to describe the time from curative intervention to recurrence (for patients who had a curative surgery).
Time to recurrence will be calculated and represented using Kaplan-Meier curves and summarized using median with 95% confidence interval. | Retrospective data capture from Jan 2018 to Dec 2021 |
Number of lines of treatment | The aim of this analysis is to describe patients' treatment patterns in LA or R/M Cervical Cancer considering the high heterogeneity of treatment options in clinical setting and the lack of real-world data in Italy. | Retrospective data capture from Jan 2018 to Dec 2021 |
The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC | Healthcare services for the present study include drug costs, general hospital costs (based on number of patient admissions and days of hospitalization, outpatients' visits, emergency access), specialist consultations and concomitant medications related to safety issue, radiological procedures, laboratory exams. | Retrospective data capture from Jan 2018 to Dec 2021 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
The proportion of patients who undergone screening program (%) | Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%). | Retrospective data capture from Jan 2018 to Dec 2021 |
HPV subtype typization, if available | Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%). | Retrospective data capture from Jan 2018 to Dec 2021 |
History of HPV related lesions (CIN 2+ lesion) | Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%). | Retrospective data capture from Jan 2018 to Dec 2021 |
The proportion of patients with PD-L1 >1% and >50% (%) | To describe the expression profile of PD-L1 (if available in archive pathology reports).
Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%). | Retrospective data capture from Jan 2018 to Dec 2021 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
- Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent & Privacy Form (ICF)
- Age ≥18 years
- Diagnosis of a cervical cancer
- Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease
- Any treatment received between January 2018 and December 2021 for advanced disease
- Patients participating in a pharmacological clinical trial for the treatment of advanced disease
- Patients who participated in a clinical trial
- Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs
MSD Italia S.r.l.Zentrale Studienkontakte
Kontakt: Stefania Lopez, +39 03626331, [email protected]
11 Studienstandorte in 1 Ländern
Bologna
Oncologia Medica Policlinico Sant'Orsola Malpighi, Bologna, Bologna, Italy
Offene Rekrutierung
Catania
Ginecologia ed Ostetricia A.O. Cannizzaro, Catania, Catania, 95126, Italy
Offene Rekrutierung
Genova
Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino, Genova, Genova, 16132, Italy
Offene Rekrutierung
Milano
Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele, Milan, Milano, 20132, Italy
Offene Rekrutierung
Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X, Milan, Milano, 30159, Italy
Offene Rekrutierung
Modena
Oncologia A.O.U. di Modena - Policlinico, Modena, Modena, 41124, Italy
Offene Rekrutierung
Napoli
U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale, Naples, Napoli, 80131, Italy
Offene Rekrutierung
UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli, Naples, Napoli, 80138, Italy
Offene Rekrutierung
Pordenone
IRCCS Centro di Riferimento Oncologico (CRO), Aviano, Pordenone, 33081, Italy
Offene Rekrutierung
Roma
U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli, Roma, Roma, 00168, Italy
Offene Rekrutierung
Venezia
UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima, Mestre, Venezia, Italy
Noch nicht rekrutierend