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Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer (MITO 22)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02408536
Recruitment Status : Unknown
Verified July 2017 by National Cancer Institute, Naples.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

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

Condition or disease
Low-grade Serous Ovarian Carcinoma Recurrent Invasive Borderline Serous Ovarian Cancer

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort
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



Primary Outcome Measures :
  1. risk of recurrence in patients with low-grade serous ovarian carcinoma [ Time Frame: two years ]
  2. number of patients with objective tumor response after receiving chemotherapy [ Time Frame: 6 months ]
  3. number of patients with objective tumor response after receiving hormone therapy [ Time Frame: 6 months ]
  4. number of patients with objective tumor response after receiving combination hormonal and chemotherapy [ Time Frame: 6 months ]
  5. progression free survival [ Time Frame: 2 years ]
  6. overall survival [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Archival tissue tumor samples in paraffin blocks for evaluation of diagnosis and biomarkers


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408536


Contacts
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Contact: Francesco Perrone, MD PhD +39 081 5903571 datamanager@usc-intnapoli.net
Contact: Teresa Ribecco, PhD +39 081 5903619 teresa.ribecco@usc-intnapoli.net

Locations
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Italy
Istitute Nazionale Tumori - Fondazione G. Pascale Recruiting
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Sandro Pignata, MD PhD NCI Naples
Principal Investigator: Chiara Della Pepa, MD NCI Naples
Principal Investigator: Francesco Perrone, MD PhD NCI Naples
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT02408536    
Other Study ID Numbers: MITO 22
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Keywords provided by National Cancer Institute, Naples:
chemotherapy
hormone therapy
borderline
low-grade
serous ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type