Low-grade Serous Ovarian CarcinomaMITO 22NCT02408536
Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer
An observational study of Low-grade Serous Ovarian Carcinoma and Recurrent Invasive Borderline Serous Ovarian Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low-grade Serous Ovarian Carcinoma, Recurrent Invasive Borderline Serous Ovarian Cancer
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- High-grade serous, mucinous, endometrioid, or any other non-low-grade serous ovarian carcinoma
- Unavailability of archival tumor specimen
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istitute Nazionale Tumori - Fondazione G. Pascale
Naples
About this study
The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.
- Keywords
- chemotherapy, hormone therapy, borderline, low-grade, serous ovarian cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of recurrence in patients with low-grade serous ovarian carcinoma
Measured: two years
number of patients with objective tumor response after receiving chemotherapy
Measured: 6 months
number of patients with objective tumor response after receiving hormone therapy
Measured: 6 months
number of patients with objective tumor response after receiving combination hormonal and chemotherapy
Measured: 6 months
progression free survival
Measured: 2 years
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-grade Serous Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandro Pignata, MD PhD, Principal investigator, NCI NaplesChiara Della Pepa, MD, Principal investigator, NCI NaplesFrancesco Perrone, MD PhD, Principal investigator, NCI Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408536
- Sponsor's protocol ID
- MITO 22
- Acronym
- MITO 22
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2015
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35869143
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02408536
- Acronym / sponsor ID
- MITO 22 / MITO 22
- Keywords
- chemotherapy, hormone therapy, borderline, low-grade, serous ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- High-grade serous, mucinous, endometrioid, or any other non-low-grade serous ovarian carcinoma
- Unavailability of archival tumor specimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 35869143Musacchio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Pignata, MD PhD principal investigator
NCI Naples
Chiara Della Pepa, MD principal investigator
NCI Naples
Francesco Perrone, MD PhD principal investigator
NCI Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-grade Serous Ovarian Carcinoma and Recurrent Invasive Borderline Serous Ovarian Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Perrone, MD PhD (+39 081 5903571, datamanager@usc-intnapoli.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of recurrence in patients with low-grade serous ovarian carcinoma (time frame: two years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.