Clinical trial NCT04248231: CINSARC Genomic Signature as Predictor of Resectability of Ovarian Adenocarcinoma
Official title: The CINSARC Genomic Signature as a Predictor of Resectability of High Grade Serous Ovarian Adenocarcinomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Adenocarcinoma
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective study on medical, clinical, pathologic data from patients primary treated for ovarian adenocarcinoma . 150 cases analyzed

Brief summary: The majority of primary cancers of the ovary or peritoneum are represented by high-grade serous adenocarcinomas. These are rare pathologies, the incidence of which is estimated at 7.1 per 100,000, representing approximately 4,500 new cases per year in France (INCA 2017). In the absence of effective screening, nearly 85% of patients have an advanced disease at diagnosis (corresponding to the FIGO III or IVA stage, characterized by diffuse peritoneal involvement). Despite multidisciplinary care, the majority of patients (80%) will recur within a median of 18 to 24 months.

It is therefore necessary to develop new tools, in particular molecular, in order to allow :

* to better select patients accessible to full interval surgery
* to exclude patients who would not benefit from this surgery in terms of survival

In 2010, Chibon et al. identified, from a cohort of patients with soft tissue sarcoma (STM), a molecular signature (called CINSARC), based on the expression profile of 67 genes involved in mitotic control and chromosomal integrity. The team showed that this transcriptomic signature is an independent prognostic factor in different types of STM, but also a prognostic factor more discriminating than the histological grade (FNCLCC), historical and major prognostic factor of STM.

Being initially made from frozen material and on a DNA biochip (Affymetrix), this signature was unusable outside the field of fundamental research. This is why CINSARC has been gradually optimized, first by the RNA sequencing technique on frozen tissue fixed in formalin (FFPE), and recently on FFPE tissue by the NanoString® technique. This very sensitive and inexpensive technique requires only small amounts of total RNA, making it compatible with use on "routine" diagnostic samples, microbiopsy or surgical biopsy, opening the door to real clinical application. Several clinical studies using this latest CINSARC optimization (called NanoCind®) to determine the treatment of patients with STM will also begin soon.

As a result of this work, necessary in order to more precisely support the potential of CINSARC in this pathology, the investigators hope to be able to assess from the diagnosis the evolutionary potential of the patients, which could make it possible to evaluate therapeutic strategies adapted to the profiles of each subpopulation: the investigators can for example imagine in theory a therapeutic de-escalation for low-risk patients, or else, for very high-risk patients, an intensified strategy.

Detailed description: RNA extraction from 150 patients archival tumor, fragments of 50 to 300 nucleotides size.

RNA preparation, hybridation, detection, scanning according to Nanostring manufacturer recommandations: obtention of CINSARC molecular signature Sensibility, specificity, prognostic value of the signature will be analyzed

Eligibility criteria: Inclusion Criteria:

* Patients with ovarian adenocarcinoma treated in IUCTO Toulouse by primary chemotherapy and for whom diagnosis tumoral sample is available

Exclusion Criteria:

* None

Primary outcomes:
measure: The main endpoint is the sensitivity of the CINSARC signature to identify surgical resectability after neoadjuvant chemotherapy.
timeFrame: sept 2019-sept 2020
Secondary outcomes:
measure: Specificity of the CINSARC signature
timeFrame: sept 2019-sept 2020
measure: Positive predictive value of the signature
timeFrame: sept 2019-sept 2020
measure: Negative predictive value of the signature
timeFrame: sept 2019-sept 2020
measure: Global survival
timeFrame: sept 2019-sept 2020
measure: Progression Free survival
timeFrame: sept 2019-sept 2020
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud Institut Universitaire du cancer Toulouse Oncopole
Study officials:
References: