Clinical trial NCT02408536: Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer
Official title: Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low-grade Serous Ovarian Carcinoma
Recurrent Invasive Borderline Serous Ovarian Cancer
Keywords: chemotherapy
hormone therapy
borderline
low-grade
serous ovarian cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed, from 01/01/2000 to 01/01/2014, with low-grade serous ovarian carcinoma or with invasive recurrence after surgery for borderline serous carcinoma

Brief summary: The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis low-grade serous ovarian carcinoma
* OR invasive recurrence after surgical resection of borderline serous ovarian carcinoma
* Availability of archival tumor specimen (paraffin embedded block) for central analysis and evaluation for mutations
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* High-grade serous, mucinous, endometrioid, or any other non-low-grade serous ovarian carcinoma
* Unavailability of archival tumor specimen

Primary outcomes:
measure: risk of recurrence in patients with low-grade serous ovarian carcinoma
timeFrame: two years
measure: number of patients with objective tumor response after receiving chemotherapy
timeFrame: 6 months
measure: number of patients with objective tumor response after receiving hormone therapy
timeFrame: 6 months
measure: number of patients with objective tumor response after receiving combination hormonal and chemotherapy
timeFrame: 6 months
measure: progression free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istitute Nazionale Tumori - Fondazione G. Pascale
Study officials:
affiliation: NCI Naples
name: Sandro Pignata, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: Chiara Della Pepa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: Francesco Perrone, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Musacchio L, Califano D, Bartoletti M, Arenare L, Lorusso D, Losito NS, Cormio G, Greggi S, Raspagliesi F, Valabrega G, Salutari V, Pisano C, Spina A, Russo D, Del Sesto M, Canzonieri V, Ferrau F, Zannoni GF, Loizzi V, Ghizzoni V, Casanova C, Tuninetti V, Ducceschi M, Del Vecchio V, Scalone S, Priolo D, Perrone F, Scambia G, Pignata S. Clinical characteristics and molecular aspects of low-grade serous ovarian and peritoneal cancer: a multicenter, observational, retrospective analysis of MITO Group (MITO 22). Br J Cancer. 2022 Nov;127(8):1479-1486. doi: 10.1038/s41416-022-01897-1. Epub 2022 Jul 22.