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

Last updated: August 2, 2023
Sponsor: Centro di Riferimento Oncologico - Aviano
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cysts

Treatment

liquid biopsy

Clinical Study ID

NCT05874115
CRO2019.053
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female patients aged ≥18 years
  2. Histological diagnosis of epithelial carcinoma of the ovary or fallopian tubes orprimary 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 theCRO 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

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 orearly stage squamous cell or basal cell carcinoma of the skin, as long as they areadequately treated.
  3. Active infection or uncontrolled chronic inflammatory disease

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: liquid biopsy
Phase:
Study Start date:
October 17, 2019
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Centro di Riferimento Oncologico (CRO), IRCCS

    Aviano,
    Italy

    Active - Recruiting

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