Clinical trial NCT01061619: Pathway to Diagnosis of Ovarian Cancer
Official title: Pathway to Diagnosis of Ovarian Cancer: Observational Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: prediagnostic symptoms
sentinel events
pathway to diagnosis
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2010-02-03
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of ovarian cancer, presenting for first-line chemotherapy

Brief summary: The purpose of this study is to describe the prediagnostic symptoms and the events along the pathway to diagnosis of women with ovarian cancer, referred for first-line chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of ovarian cancer
* Indication for chemotherapy
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy
* Unable or unwilling to participate in interview

Primary outcomes:
measure: the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis
timeFrame: at baseline
measure: time intervals in weeks between prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)
timeFrame: at baseline
measure: description of prediagnostic patient experiences according to modified Andersen's model of 'total patient delay'
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven-Gynecological Oncology,
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Campus Virchow-Klinikum / Frauenklinik
city: Bari
country: Italy
facility: IRCCS Oncologico Bari, Oncologia Medica
state: BA
city: Bergamo
country: Italy
facility: Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
state: BG
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli, U.O. di Oncologia
state: BN
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
state: BN
city: Campobasso
country: Italy
facility: Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
state: CB
city: Mantova
country: Italy
facility: Azienda Ospedaliera C. Poma
state: MN
city: Palermo
country: Italy
facility: Azienda Ospedaliera V. Cervello
state: PA
city: Penne
country: Italy
facility: Ospedale S. Massimo, Day Hospital Oncologico
state: PE
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
state: PN
city: Trento
country: Italy
facility: Ospedale S. Chiara
state: TN
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
state: VI
city: Ascoli Piceno
country: Italy
facility: Ospedale Mazzoni
city: Bari
country: Italy
facility: Policlinico Universitario
city: Bari
country: Italy
facility: Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli
city: Brindisi
country: Italy
facility: Ospedale Senatore Antonio Perrino
city: Campobasso
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: Modena
country: Italy
facility: A.O. Univeristaria Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera D. Cotugno
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
city: Napoli
country: Italy
facility: Università Federico II, Cattedra di Oncologia Medica
city: Perugia
country: Italy
facility: Ospedale Silvestrini
city: Pescara
country: Italy
facility: Ospedale Civile S. Spirito
city: Pordenone
country: Italy
facility: A.O. S. Maria degli Angeli
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
city: Udine
country: Italy
facility: A.O. di Udine S. Maria della Misericordia
Study officials:
affiliation: National Cancer Institute, Naples
name: Sandro Pignata, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Alessandro Morabito, M.D.,
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Ciro Gallo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Jane Bryce, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: S. Giuseppe Moscati Hospital, Avellino
name: Marzia Falanga, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Carmen Pisano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Marilina Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Massimo Di Maio, M.D.
role: PRINCIPAL_INVESTIGATOR
References: