To determine prospectively the correlation between in vitro patient-derived organoid response and progression-free survival.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression-free survival.
Secondary outcome
• Response at first, second, and/or following evaluations after treatment with
standard-of-care drugs as measured by the change in tumor size on a CT scan
(continuous variable)
• Response at patient level according to RECIST 1.1 (categorical variable)
• Response at patient level according to CA-125 levels (continuous variable)
• Assess above mentioned end-points per specified subgroups:
o per treatment line (platinum-naïve, platinum-sensitive, or
platinum-resistance)
o per histopathological subtype (high-grade serous or others)
o per type of treatment given (carboplatin-paclitaxel with or without PARPi or
bevacizumab maintenance therapy, carboplatin-gemcitabine with or without PARPi
or bevacizumab maintenance therapy, weekly paclitaxel, etoposide,liposomal
doxorubicin or early clinical trial compound).
• Yield/feasibility of organoid culture and tumor cell line (2D) culture
Background summary
Epithelial ovarian carcinoma (EOC) is a highly lethal gynecological malignancy
often diagnosed at an advanced stage, resulting in low survival rates. Current
treatment strategies include debulking surgery and platinum-based chemotherapy.
Primary and acquired chemoresistance leading to treatment failure and high
recurrence rates remain significant challenges. This study aims to address
these issues by using patient-derived organoids (PDOs) to predict treatment
response.
Study objective
To determine prospectively the correlation between in vitro patient-derived
organoid response and progression-free survival.
Study design
A unicenter observational cohort study from March 2024 until July 2027. Tumor
tissue from diagnostic biopsies, debulking surgeries, and/or ascites drainage
will be collected for organoid culture. In vitro organoid responses to
treatment will be compared to clinical treatment outcomes.
Study burden and risks
Extensive experience exists with performing debulking surgeries, diagnostic
biopsies, and ascites drainage in patients with EOC, and these procedures are
considered to be safe and an essential part of standard of care. Trial
participation is not expected to offer significant patients benefit.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a subject must meet all of the
following criteria:
1. Patients diagnosed with (the suspicion of) epithelial ovarian carcinoma
amenable for standard-of-care systemic treatment in the adjuvant or recurrent
setting, including, but not limited to:
Treatment for primary advanced stage EOC:
1.1. Carboplatin/paclitaxel + PARP inhibitor* (including repeated cycles)
1.2. Carboplatin/gemcitabine + PARP inhibitor* (only if not administered yet)
1.3. Carboplatin/gemcitabine + bevacizumab (including repeated cycles)
Treatment for recurrent advanced stage EOC:
1.4. Paclitaxel (weekly) +/- bevacizumab
1.5. Etoposide
1.6. Liposomal doxorubicin
1.7. Early phase clinical trial compound(s)
1.8. Treatments outside the above-mentioned standard-of-care regimens can be
considered but must be approved by the study*s P.I. before including patients.
* PARP inhibitors incl.: registered olaparib, niraparib and rucaparib.
Talazoparib and veliparib are still under investigation in clinical trials.
2. Patients age >=18 years, willing and able to comply with the protocol as
judged by the investigator with a signed informed consent.
3. Patients with neoadjuvant treatment or recurrent disease must have
radiographically evaluable disease, either measurable or non-measurable per
RECIST 1.1, as assessed by the local site investigator/radiology.
Patients starting a new line of treatment after participation in this trial are
eligible to participate again. Informed consent, baseline screening, and the
diagnostic biopsy procedure must be repeated.
Exclusion criteria
• Patients with unrelated secondary tumors that in the opinion of the
investigator interfere with treatment decision making, affect response
evaluation of pose a competing risk for survival.
• Patients who underwent a diagnostic biopsy due to suspicion of EOC, but
histological examination did not confirm this diagnosis.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85296.041.23 |