CINSARC Genomic Signature as Predictor of Resectability of Ovarian Adenocarcinoma

Ovarian Adenocarcinoma Clinical Trial

— OVASARC  

Official title:

The CINSARC Genomic Signature as a Predictor of Resectability of High Grade Serous Ovarian Adenocarcinomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248231
• Other study ID #: 18HLGENF05
• Status: Completed
• Start date: September 15, 2019
• Est. completion date: December 23, 2021

Study information

• Verified date: December 2022
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 23, 2021
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Ovarian Epithelial
• Ovarian Adenocarcinoma

Intervention

Other:
• CINSARC signature
CINSARC molecular signature analysis

Locations

Country	Name	City	State
France	Institut Claudius Regaud Institut Universitaire du cancer Toulouse Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main endpoint is the sensitivity of the CINSARC signature to identify surgical resectability after neoadjuvant chemotherapy.	Sensitivity (Se), is defined by the proportion of subjects defined as Low risk by the CINSARC signature and having been resected, among the subjects having been resected	sept 2019-sept 2020
Secondary	Specificity of the CINSARC signature	Proportion of subjects defined as high risk by the signature and having not been resected among patients having not been resected	sept 2019-sept 2020
Secondary	Positive predictive value of the signature	Proportion of subjects defined as Low risk by the signature among all subjects	sept 2019-sept 2020
Secondary	Negative predictive value of the signature	Proportion of subjects defined as High risk by the signature among all subjects	sept 2019-sept 2020
Secondary	Global survival	Time frame between diagnosis date of advanced stage / metastatic stage and date of death or last news	sept 2019-sept 2020
Secondary	Progression Free survival	Time frame between date of diagnosis of advanced stage / metastatic stage and date of either progression or death or last news	sept 2019-sept 2020