Development of a Biomarker to Predict the Efficacy of Anti-angiogenic Therapy in Ovarian Cancer

NCT ID: NCT05874115

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-17
• Study Completion Date: 2024-05-31

Brief 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.

Conditions

Epithelial Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

liquid biopsy

liquid biopsy

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurizio Maurizio

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico (CRO), IRCCS

Locations

Centro di Riferimento Oncologico (CRO), IRCCS

Aviano, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maurizio Maurizio

Role: CONTACT

mmongiat@cro.it

+390434659516

Facility Contacts

Maurizio Mongiat

Role: primary

mmongiat@cro.it

Other Identifiers

CRO2019.053

Identifier Type: -

Identifier Source: org_study_id