Evaluation of the Predictive Value of Blood Levels of Angiopoietin 1 and Endothelial Internal Tunica Cell Kinase 2 in Patients With Ovarian Cancer Treated With Chemotherapy Associated to Bevacizumab

December 28, 2022 updated by: Claudio Zamagni MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Prospective Pilot Study for the Evaluation of the Predictive Value of Blood Levels of Angiopoietin 1 (ANG1) and Endothelial Internal Tunica Cell Kinase 2 (TiE2) in Patients With Ovarian Cancer Treated With Chemotherapy Associated to bevAcizumab

This is a monocentric prospective observational pilot study of translational research in women with advanced ovarian epithelial cancer. The main purpose of this study is to evaluate the predictive value of response to treatment with bevacizumab of the circulating levels of Ang1, Tie2 and VEGF before start of therapy. Secondary aims of the study are to explore the predictive value of response / resistance to bevacizumab of changes in circulating levels of Ang1 and Tie2 during treatment and at progression of disease, and to explore the possible role of circulating VEGF in the modulation of bioavailability of bevacizumab.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

A sample size of 100 patients with advanced epithelial ovarian carcer is expected to be enrolled in Cohort A (I-II line of chemotherapy associated to bevacizumab) and 50 patients with advanced epithelial ovarian carcer is expected to be enrolled in Cohort B (I-II line of chemotherapy, not associated to antiangiogenic drugs)

Description

Inclusion Criteria:

  • Patients ≥ 18 years old
  • Diagnosis of histologically confirmed advanced epithelial ovarian carcinoma
  • Women eligible for treatment with a chemotherapy regimen in combination to bevacizumab (Cohort A)
  • Women eligible for treatment with a chemotherapy regimen not associated to antiangiogenic drugs (Cohort B)
  • Evaluable disease according to RECIST 1.1 criteria
  • Patient informed consent signature prior to any study-specific procedure

Exclusion Criteria:

  • History of other malignancy within 5 years prior to study entry (except for cutaneous basal cell carcinoma or adequately treated carcinoma in situ of the cervix ).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A: patients treated with chemotherapy (I-II line) associated to bevacizumab
Quantification of biomarkers will be performed on 100 patients treated with bevacizumab through the collection of the following samples at different timepoints: 1 serum sample; 2 CTAD plasma samples; 2 K2EDTA plasma samples. The samples will be collected as follows: before the start of chemotherapy; 3 weeks after start of chemotherapy, before start of treatment with bevacizumab; 9 weeks after start of chemotherapy; 15 weeks after start of chemotherapy; 52 weeks after start of chemotherapy; at progression of disease.
Other: Observational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.
Collection of blood samples during blood draws performed before each cycle of chemotherapy as per clinical practice.
Cohort B: patients treated with chemotherapy (I-II line, not associated to antiangiogenic drugs)
Quantification of biomarkers will be performed on 50 patients treated with chemotherapy through the collection of the following samples at different timepoints: 1 serum sample; 2 CTAD plasma samples; 2 K2EDTA plasma samples. The samples will be collected as follows: before the start of chemotherapy; 3 weeks after start of chemotherapy, before start of treatment with bevacizumab; 9 weeks after start of chemotherapy; 15 weeks after start of chemotherapy; 52 weeks after start of chemotherapy; at progression of disease.
Other: Observational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.
Collection of blood samples during blood draws performed before each cycle of chemotherapy as per clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relationship between Ang1 and Tie2 values and response to treatment with bevacizumab
Time Frame: Before start of chemotherapy
Relationship between baseline values of Ang1 and Tie2 (considered individually or combined with each other) and response to treatment with bevacizumab (according to RECIST 1.1 criteria).
Before start of chemotherapy
relationship between VEGF values and response to treatment with bevacizumab
Time Frame: Before start of chemotherapy
Relationship between baseline values of endogenous VEGF (plasma CTAD levels) and released by platelets during the clot phase (serum levels) and response to treatment with bevacizumab.
Before start of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relationship between Ang1 and Tie2 levels
Time Frame: from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease
relationship between Ang1 and Tie2 levels at baseline, during chemotherapy administration and at progression of disease.
from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease
anticipation of diagnosis of progression of disease
Time Frame: from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease
possible anticipation of diagnosis of progression of disease through evaluation of Ang1 and Tie2
from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease
VEGF evaluation
Time Frame: from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease
Evaluation of free VEGF, bevacizumab-bound VEGF and available bevacizumab in relation to clinical response
from baseline (before start of chemotherapy) to 52 weeks from start of chemotherapy or progression of disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborators

Ospedale SS Giovanni e Paolo, Venezia

Investigators

  • Principal Investigator: Claudio Zamagni, MD, Policlinico S.Orsola-Malpighi, SSD Oncologia Medica Addarii

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANGEA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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