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

NCT05874115 | Unknown

• 1 other identifier: CRO2019.053
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

liquid biopsy OTHER

liquid biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with histological diagnosis of epithelial ovarian carcinoma (EOC),consecutively referred to the IRCCS CRO of Aviano in the study period

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico (CRO), IRCCS

Aviano, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Maurizio Maurizio

  Centro di Riferimento Oncologico (CRO), IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Maurizio

CONTACT

+390434659516; mmongiat@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 24, 2023
• Study Start: October 17, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)