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

Epithelial Ovarian Cancer Clinical Trial

— OutCoME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874115
• Other study ID #: CRO2019.053
• Status: Recruiting
• Start date: October 17, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Maurizio Maurizio
• Phone: +390434659516
• Email: mmongiat[@]cro.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• liquid biopsy
liquid biopsy

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico (CRO), IRCCS	Aviano

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
Primary	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	from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years
Primary	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	from EOC diagnosis diagnosis until first documented progression or death from any cause, up to 2 years