Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA).

Ovarian Cancer Clinical Trial

— PANDORA  

Official title:

Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229522
• Other study ID #: CRO-2022-45
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: December 31, 2037

Study information

• Verified date: January 2024
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Vincenzo Canzonieri, MD
• Phone: 0434659618
• Email: vcanzonieri[@]cro.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and/or promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients.

Description:

The association of clinical, pathogenesis and mutational profile of patients affected by ovarian cancer have improved the armamentarium of therapies available for medical doctors. One of most remarkable advancements is represented by the introduction of PARP inhibitors in the front-line setting of advanced ovarian carcinoma. It is necessary to continue with this effort and introduce novel approaches to improve the survival rate as well as predictive biomarkers to approved therapies. Given the absence of predictive biomarkers to standard therapy, patients derived organoid could be a promising platform to test clinically available drugs and/or promising new molecules to explore the tumor sensibility in an ex-vivo model. The aim of this study is to correlate treatment sensibility measured in tumor derived organoids to clinical sensibility seen in real world patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2037
• Est. primary completion date: December 31, 2037
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent form;

2. Female sex;

3. Age =18 years;

4. Diagnosis of ovarian cancer;

5. Availability of tumor sample or ascites that is planned to be stored in the Institutional Biobank for research purpose

Exclusion Criteria:

1. Patients for which the tumor/ascites biobanking process could compromise the diagnostic assessments;

2. Pregnancy or breast-feeding

3. History of concomitant or previous malignancy in the last 5 years

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS	Aviano	Pordenone

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess if the drugs' sensibility tested in the 3D organoids derived from biopsies could predict the clinical response (PFS) to therapy regimen for each individual ovarian cancer patient.	Patients will be divided into two groups based on IC50 level. Difference in PFS probability between patients with high or low IC50 level will be assessed. Progression-free survival (PFS) will be defined as time from enrolment to progression or death whichever comes first	up to 36 months
Primary	To assess if the drugs' sensibility tested in the 3D organoids derived from ascites fluids could predict the clinical response (PFS) to therapy regimen for each individual ovarian cancer patient.	Patients will be divided into two groups based on IC50 level. Difference in PFS probability between patients with high or low IC50 level will be assessed. Progression-free survival (PFS) will be defined as time from enrolment to progression or death whichever comes first	up to 36 months
Primary	To assess if the drugs' sensibility tested in the 3D organoids derived from biopsies could predict the clinical response (PFI) to therapy regimen for each individual ovarian cancer patient.	Patients will be divided into two groups based on IC50 level. Difference in platinum-free interval for platinum salts (PFI) probability between patients with high or low IC50 level will be assessed. PFI will be defined as time from the date of last dose of first line chemotherapy to the date of first recurrence.	up to 36 months
Primary	To assess if the drugs' sensibility tested in the 3D organoids derived from ascites fluid could predict the clinical response (PFI) to therapy regimen for each individual ovarian cancer patient.	Patients will be divided into two groups based on IC50 level. Difference in platinum-free interval for platinum salts (PFI) probability between patients with high or low IC50 level will be assessed. PFI will be defined as time from the date of last dose of first line chemotherapy to the date of first recurrence.	up to 36 months