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OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

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Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer

NCT02408536UNKNOWNOBSERVATIONAL

Summary

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

Key Facts

Lead Sponsor

National Cancer Institute, Naples

Enrollment

150

Start Date

2014-10-01

Completion Date

2023-12-01

Study Type

OBSERVATIONAL

Official Title

Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer

Conditions

Low-grade Serous Ovarian CarcinomaRecurrent Invasive Borderline Serous Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

risk of recurrence in patients with low-grade serous ovarian carcinoma

Time frame: two years

number of patients with objective tumor response after receiving chemotherapy

Time frame: 6 months

number of patients with objective tumor response after receiving hormone therapy

Time frame: 6 months

number of patients with objective tumor response after receiving combination hormonal and chemotherapy

Time frame: 6 months

progression free survival

Time frame: 2 years

overall survival

Time frame: 5 years

Locations

Istitute Nazionale Tumori - Fondazione G. Pascale, Naples, Italy

Linked Papers

2022-07-22

Clinical characteristics and molecular aspects of low-grade serous ovarian and peritoneal cancer: a multicenter, observational, retrospective analysis of MITO Group (MITO 22)

Low-grade serous ovarian and peritoneal cancer (LGSC) is a rare disease and few data on the clinical and genomic landscape have been published. A retrospective analysis of patients diagnosed with LGSC between 1996 and 2019 was conducted in MITO centers. Objective Response Rate (ORR) to treatments, progression-free survival (PFS) and overall survival (OS) were assessed. Additionally, the tumor molecular profile of 56 patients was evaluated using the Next Generation Sequencing (NGS) FoundationOne CDX (Foundation Medicine®). A total of 128 patients with complete clinical data and pathologically confirmed diagnosis of LGSC were identified. ORR to first and subsequent therapies were 23.7% and 33.7%, respectively. PFS was 43.9 months (95% CI:32.4-53.1) and OS was 105.4 months (95% CI: 82.7-not reached). The most common gene alterations were: KRAS (n = 12, 21%), CDKN2A/B (n = 11, 20%), NRAS (n = 8, 14%), FANCA (n = 8, 14%), NF1 (n = 7, 13%) and BRAF (n = 6, 11%). Unexpectedly, pathogenetic BRCA1 (n = 2, 4%), BRCA2 (n = 1, 2%) and PALB2 (n = 1, 2%) mutations were found. MITO 22 suggests that LGSC is an heterogenous disease for both its clinical behavior in response to standard therapies and its molecular alterations. Future prospective studies should test treatments according to biological and molecular tumor's characteristics. This study is registered under NCT02408536 on ClinicalTrials.gov .

Linked Investigators

Sandro Pignata