Epithelial Ovarian CancerOutCoMENCT05874115
Development of a Biomarker to Predict the Efficacy of Anti-angiogenic Therapy in Ovarian Cancer
An observational study of Epithelial Ovarian Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
Epithelial ovarian cancer (EOC) is a highly angiogenic tumor and drug targeting of angiogenesis is effective in some selected groups of EOC patients. However, no biomarkers are available to predict the effectiveness of this expensive therapy.Investigators believe that Multimerin-2, an extracellular matrix molecule… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- liquid biopsy
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 17 Oct 2019to 31 May 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: Women with histological diagnosis of epithelial ovarian carcinoma (EOC),consecutively referred to the IRCCS CRO of Aviano in the study period
Who may be able to join
- Female patients aged ≥18 years
- Histological diagnosis of epithelial carcinoma of the ovary or fallopian tubes or primary carcinoma of the peritoneum, including mixed Mullerian tumours.
- Stage IIIb, IIIc or IV
- Performance Status 0-2 according to ECOG
- Availability of tumor tissue samples and biological fluids for molecular analyses
- Informed consent for the collection, storage and use of biological material for the CRO Biobank (as specified in the consent of the CRO Biobank, Rev 2 of 03/10/2016), signed and obtained before surgery for suspected EOC.
Who cannot join
- Ovarian tumors of low malignant potential (i.e. borderline tumors)
- Other malignacies within the last 5 years except carcinoma in situ of the cervix or early stage squamous cell or basal cell carcinoma of the skin, as long as they are adequately treated.
- Active infection or uncontrolled chronic inflammatory disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO), IRCCS
Aviano
Maurizio Mongiat, mmongiat@cro.it
Milena Nicoloso
About this study
Epithelial ovarian cancer (EOC) is a highly angiogenic tumor and drug targeting of angiogenesis is effective in some selected groups of EOC patients. However, no biomarkers are available to predict the effectiveness of this expensive therapy.Investigators believe that Multimerin-2, an extracellular matrix molecule, could serve as a biomarker that can address this clinical need. Multimerin-2 is deposited throughout the vasculature and its expression in EOC-associated vessels is frequently lost, in part due to increased degradation. Multimerin-2 sequesters VEGFA and other angiogenic factors and their release upon degradation of Multimerin-2 could underlie resistance to anti-angiogenic therapy. Indeed, fragments of degradation of Multimerin-2 are found in high concentrations in sera of EOC patients. Furthermore, the loss of Multimerin-2 impairs the function of the vessels, and this could negatively affect the delivery of the drug and the efficacy of the treatment.
With the aim of predicting the efficiency of anti-angiogenic therapy, researchers will evaluate the angiogenic properties and expression of Multimerin-2 in EOC tumors, and develop a new Multimerin-2-based biomarker detectable by liquid biopsy, in order to manage EOC patients in a targeted manner based on the biological characteristics of their tumor.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- liquid biopsy
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid biopsyOther
liquid biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Multimerin-2 levels and progression free survival
To investigate whether Multimerin-2 level measured in serum could represent a potential prognostic biomarker (measured as progression free survival) in bevacizumab-treated subjects
Measured: from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
Multimerin-2 levels and progression free survival
To investigate whether Multimerin-2 level measured in urine could represent a potential prognostic biomarker (measured as progression free survival) in bevacizumab-treated subjects
Measured: from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
Multimerin-2 levels and progression free survival
To investigate whether Multimerin-2 level measured in ascites could represent a potential prognostic biomarker (measured as progression free survival) in bevacizumab-treated subjects
Measured: from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start17 Oct 2019
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies 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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Maurizio, Principal investigator, Centro di Riferimento Oncologico (CRO), IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874115
- Sponsor's protocol ID
- CRO2019.053
- Acronym
- OutCoME
- Status last verified
- Aug 2023
- First submitted
- 26 Apr 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Biomarker to Predict the Efficacy of Anti-angiogenic Therapy in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05874115
- Acronym / sponsor ID
- OutCoME / CRO2019.053
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 24 May 2023 (actual)
- 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.
Epithelial ovarian cancer (EOC) is a highly angiogenic tumor and drug targeting of angiogenesis is effective in some selected groups of EOC patients. However, no biomarkers are available to predict the effectiveness of this expensive therapy.Investigators believe that Multimerin-2, an extracellular matrix molecule, could serve as a biomarker that can address this clinical need. Multimerin-2 is deposited throughout the vasculature and its expression in EOC-associated vessels is frequently lost, in part due to increased degradation. Multimerin-2 sequesters VEGFA and other angiogenic factors and their release upon degradation of Multimerin-2 could underlie resistance to anti-angiogenic therapy. Indeed, fragments of degradation of Multimerin-2 are found in high concentrations in sera of EOC patients. Furthermore, the loss of Multimerin-2 impairs the function of the vessels, and this could negatively affect the delivery of the drug and the efficacy of the treatment.
With the aim of predicting the efficiency of anti-angiogenic therapy, researchers will evaluate the angiogenic properties and expression of Multimerin-2 in EOC tumors, and develop a new Multimerin-2-based biomarker detectable by liquid biopsy, in order to manage EOC patients in a targeted manner based on the biological characteristics of their tumor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with histological diagnosis of epithelial ovarian carcinoma (EOC),consecutively referred to the IRCCS CRO of Aviano in the study period
Key inclusion criteria (6 listed)
- Female patients aged ≥18 years
- Histological diagnosis of epithelial carcinoma of the ovary or fallopian tubes or primary carcinoma of the peritoneum, including mixed Mullerian tumours.
- Stage IIIb, IIIc or IV
- Performance Status 0-2 according to ECOG
- Availability of tumor tissue samples and biological fluids for molecular analyses
Key exclusion criteria (3 listed)
- Ovarian tumors of low malignant potential (i.e. borderline tumors)
- Other malignacies within the last 5 years except carcinoma in situ of the cervix or early stage squamous cell or basal cell carcinoma of the skin, as long as they are adequately treated.
- Active infection or uncontrolled chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liquid biopsyliquid biopsy | Other | – |
Primary outcome
Multimerin-2 levels and progression free survival
Time frame: from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
To investigate whether Multimerin-2 level measured in serum could represent a potential prognostic biomarker (measured as progression free survival) in bevacizumab-treated subjects
Multimerin-2 levels and progression free survival
Time frame: from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
To investigate whether Multimerin-2 level measured in urine could represent a potential prognostic biomarker (measured as progression free survival) in bevacizumab-treated subjects
Multimerin-2 levels and progression free survival
Time frame: from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
To investigate whether Multimerin-2 level measured in ascites could represent a potential prognostic biomarker (measured as progression free survival) in bevacizumab-treated subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Maurizio Maurizio principal investigator
Centro di Riferimento Oncologico (CRO), IRCCS
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 Epithelial Ovarian Cancer, run by Centro di Riferimento Oncologico - Aviano 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 6 inclusion and 3 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 3 Aug 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 Maurizio Maurizio (+390434659516, mmongiat@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multimerin-2 levels and progression free survival (time frame: from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2023.