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Trial Title:
Development of a Biomarker to Predict the Efficacy of Anti-angiogenic Therapy in Ovarian Cancer
NCT ID:
NCT05874115
Condition:
Epithelial Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
liquid biopsy
Description:
liquid biopsy
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, 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.
Criteria for eligibility:
Study pop:
Women with histological diagnosis of epithelial ovarian carcinoma (EOC),consecutively
referred to the IRCCS CRO of Aviano in the study period
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Female patients aged ≥18 years
2. Histological diagnosis of epithelial carcinoma of the ovary or fallopian tubes or
primary carcinoma of the peritoneum, including mixed Mullerian tumours.
3. Stage IIIb, IIIc or IV
4. Performance Status 0-2 according to ECOG
5. Availability of tumor tissue samples and biological fluids for molecular analyses
6. 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.
Exclusion Criteria:
1. Ovarian tumors of low malignant potential (i.e. borderline tumors)
2. 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.
3. Active infection or uncontrolled chronic inflammatory disease
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO), IRCCS
Address:
City:
Aviano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maurizio Mongiat
Email:
mmongiat@cro.it
Investigator:
Last name:
Milena Nicoloso
Email:
Principal Investigator
Investigator:
Last name:
Maurizio Mongiat
Email:
Principal Investigator
Start date:
October 17, 2019
Completion date:
May 31, 2024
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05874115
