Back to resultsPatients Derived Organoids in Ovarian Cancer (PICTURE)
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria: Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer; Histologic diagnoses of epithelial ovarian cancer at frozen section Age >18 and years; Estimated life expectancy of at least 4 weeks; Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) < 2 Exclusion Criteria: Non-serous histology at frozen section; Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.
Sites / Locations
- Policlinico Universitario Agostino GemelliRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Interventional
Arm Description
Outcomes
Primary Outcome Measures
To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model.
To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model, organoids, aimed at obtaining information on the genomic and molecular characteristics of tumor cells and cells belonging to the immune system specific to each individual ovarian cancer patient and to study their interaction.
Secondary Outcome Measures
Full Information
NCT ID
NCT06085404
First Posted
June 21, 2023
Last Updated
October 10, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT06085404
Brief Title
Patients Derived Organoids in Ovarian Cancer
Acronym
PICTURE
Official Title
Patients Derived Organoids (PDOs) Immune Cells Co-culture in Ovarian Cancer: the Role of TUmoR microEnvironment.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Among cancer models, patients derived organoids (PDOs) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response.
For these reasons, it has been designed a study to assess the feasibility of PDOs immune cells co-culture in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, PDOs could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Other Intervention Name(s)
Tumor Biopsy
Intervention Description
Patients will be enrolled starting right after Ethics Committee approval. Samples will be taken during surgery that will take place in the operating rooms of oncological gynecology.
Primary Outcome Measure Information:
Title
To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model.
Description
To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model, organoids, aimed at obtaining information on the genomic and molecular characteristics of tumor cells and cells belonging to the immune system specific to each individual ovarian cancer patient and to study their interaction.
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer;
Histologic diagnoses of epithelial ovarian cancer at frozen section
Age >18 and years;
Estimated life expectancy of at least 4 weeks;
Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) < 2
Exclusion Criteria:
Non-serous histology at frozen section;
Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Nero, PhD
Phone
0630158667
Email
camilla.nero@policlinicogemelli.it
Facility Information:
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Nero, PhD
Phone
0630158667
Email
camilla.nero@policlinicogemelli.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patients Derived Organoids in Ovarian Cancer
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