SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS (SPEED)
SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) TO DETECT MINIMAL RESIDUAL DISEASE AND EARLY RELAPSE IN ADVANCED OVARIAN CANCER PATIENTS
Ovarian cancer (OC) is the third most common gynaecologic cancer worldwide and has the highest mortality rate among gynaecologic cancers. Despite the advances in cytoreductive surgery and frontline chemotherapy, recurrence is a common event in the advanced disease setting, with more than 70% of women experiencing relapse within two years from diagnosis.
New strategies to anticipate the diagnosis of recurrence have been investigated in the last years. In this context, standard serum biomarkers, such as CA-125, and radiological evaluation are commonly used for disease surveillance, However, the early identification of relapsed disease as well as the identification of patients at higher risk for recurrence are still unmetclinical needs. Novel and reliable molecular biomarkers, which might also better represent the intrinsic molecular complexity of OC, could help clinicians to address this important challenge.
Circulating tumor DNA (ctDNA) analysis has recently emerged as a non-invasive tool to profile and monitor tumor evolution over time. CtDNA has been extensively studied in several neoplasms in order to evaluate its ability in anticipating detection of relapse compared to common markers used in clinical practice. Wehave designed a study to assess the ability of ctDNA to detect recurrence and progression of disease and to provide a genomic characterization, during follow-up of patients with advanced OC. If proven effective and reliable, ctDNA could be introduced into routine surveillance programme for OC.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Camilla Nero, PhD
- Phone Number: 0630158667
- Email: camilla.nero@policlinicogemelli.it
Study Contact Backup
- Name: Francesca Sillano
- Phone Number: 0630158667
- Email: francesca.sillano@policlinicogemelli.it
Study Locations
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-
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Roma, Italy
- Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Contact:
- Camilla Nero, PhD
- Phone Number: 0630158667
- Email: camilla.nero@policlinicogemelli.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Newly diagnosed suspicious International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater ovarian, fallopian tube, or primary peritoneal cancer
- Age between 18 and 80 years
- Estimated life expectancy of at least 4 weeks 4. Signed informed consent
Exclusion Criteria:
- Any previous cancer in the last 5 years
- Previous chemotherapy or target treatments 3. Diagnosis of synchronous tumors
- Pregnancy or breastfeeding
- Missed informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Interventional
Patients with suspected advanced OC, based on preoperative imaging/clinical evaluation, will undergo blood samples in different timepoints
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Patients with suspected advanced OC, based on preoperative imaging/clinical evaluation, will undergo blood samples in different timepoints
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To evaluate the ability of ctDNA to detect Ovarian Cancer recurrence. predictive value (NPV)).
Time Frame: 24 months
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The primary endpoint is to evaluate the ability of ctDNA to detect OC recurrence earlier than radiology (CT scan and ultrasound examination) and serum biomarkers used in clinical practice, in terms of diagnostic accuracy (i.e.
specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV)).
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Camilla Nero, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- 6065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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