Clinical trial NCT06229522: Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA).
Official title: Patients Derived Organoids as a Promising Tool to Tailor Ovarian Cancer Therapies (PANDORA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include all consecutive women with a diagnosis of ovarian cancer who fit all inclusion/exclusion criteria between the date in which the study is approved and December 2027. Follow-up information will be collected up to 10 years since enrollment.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 36 months
measure: 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.
timeFrame: up to 36 months
measure: 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.
timeFrame: up to 36 months
measure: 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.
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
name: Vincenzo Canzonieri, MD
role: PRINCIPAL_INVESTIGATOR
References: