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

NCT ID: NCT02408536

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2024-07-31

Brief Summary

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

Detailed Description

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Conditions

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Low-grade Serous Ovarian Carcinoma Recurrent Invasive Borderline Serous Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single cohort

Retrospective analysis of all patients diagnosed, from 01/01/2000 to 01/01/2014, with low-grade serous ovarian cancer or invasive recurrence after surgery for borderline serous carcinoma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Naples

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandro Pignata, MD PhD

Role: PRINCIPAL_INVESTIGATOR

NCI Naples

Chiara Della Pepa, MD

Role: PRINCIPAL_INVESTIGATOR

NCI Naples

Francesco Perrone, MD PhD

Role: PRINCIPAL_INVESTIGATOR

NCI Naples

Locations

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Istitute Nazionale Tumori - Fondazione G. Pascale

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Perrone, MD PhD

Role: CONTACT

+39 081 5903571

Teresa Ribecco, PhD

Role: CONTACT

+39 081 5903619

References

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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.

Reference Type DERIVED
PMID: 35869143 (View on PubMed)

Other Identifiers

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MITO 22

Identifier Type: -

Identifier Source: org_study_id

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