CINSARC Genomic Signature as Predictor of Resectability of Ovarian Adenocarcinoma

NCT04248231 | Completed

• 1 other identifier: 18HLGENF05
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Specificity of the CINSARC signature

  sept 2019-sept 2020

• Positive predictive value of the signature

  sept 2019-sept 2020

• Negative predictive value of the signature

  sept 2019-sept 2020

• Global survival

  sept 2019-sept 2020

• Progression Free survival

  sept 2019-sept 2020

Interventions

CINSARC signature OTHER

CINSARC molecular signature analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Retrospective study on medical, clinical, pathologic data from patients primary treated for ovarian adenocarcinoma . 150 cases analyzed

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius Regaud Institut Universitaire du cancer Toulouse Oncopole

Toulouse, 31059, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: September 15, 2019
• Primary Completion: September 15, 2020
• Study Completion: December 23, 2021
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

FR (1)