Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction (PRETORIA)

October 26, 2023 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction

This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Immediate reconstruction after mastectomy may help women with breast cancer to deal with their fear of mastectomy, spare them one or more second surgery and additional hospital stays in case of late breast reconstruction. However, in France, most patients with invasive breast carcinoma and treated with mastectomy are not offered immediate reconstruction. One reason is the need for postoperative radiotherapy for most patients (40 to 70% according to the centers). Indeed, radiotherapy induces side-effects which can alter the cosmetic result of the breast reconstruction as well as the patient's quality of life. Since 1995, a significant correlation is observed between the RILA test (measurement by flux cytometry of the lymphocyte T-CD8 apoptosis induced by radiotherapy) and the risk of occurrence of severe radio-induced breast fibrosis. Such accurate personalized medical care could allow identifying before any treatment high risk of toxicity patients and thus help establishing the therapeutic strategy. Identification of low-risk patients could also allow limiting autologous samplings and thus their associated morbidity.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Patients with histologically confirmed breast cancer with indication of mastectomy or surgery with mastectomy performed
  • Indication of wall chest radiation after mastectomy
  • Patient's agreement to receive or having had an immediate breast reconstruction by implant in one or two steps, with or without a dermal or synthetic matrix (depending on the habits of the center)
  • Performance Status 0-1
  • Consent signed before any study procedure
  • Patient geographically accessible for follow-up
  • Affiliated to the French national social security system

Exclusion Criteria:

  • Breast reconstruction with flap
  • Inflammatory breast cancer (cT4d)
  • Skin or parietal breast cancer (cT4 a, b or c)
  • Metastatic patients
  • Patients with bilateral breast cancer
  • History of homolateral breast cancer treated with radiotherapy
  • History of contralateral breast cancer
  • Pregnant or breastfeeding women
  • Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent
  • Participation in an interventional clinical study or planned participation during study up to 12 months post-radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toxicity test

For all patients, the NovaGray RILA Breast® test will be performed between day -30 and until the first day of radiotherapy (before the start of this one) and then 12 months after the end of radiotherapy and in the case of neoadjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection) and in the case of adjuvant chemotherapy, between day -30 and until the first day of chemotherapy (before any injection).

The test consists of a blood sample of 2x4 mL
Device: NovaGray RILA Breast® test
The test consists of a blood sample of 2x4 mL. This test will be performed between day -30 and until the first day of radiotherapy (before the start of this one) and then 12 months after the end of radiotherapy and between day -30 and until the first day of chemotherapy (before any injection) in the case of neoadjuvant chemotherapy and between day -30 and until the first day of chemotherapy (before any injection) in the case of adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of a radiosensitivity test to predict capsular contracture
Time Frame: 12 months after the end of radiotherapy
To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture
12 months after the end of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capsular contracture prevalence
Time Frame: 12 Months
Rate of capsular contracture after radiotherapy
12 Months
Accuracy of the dichotomized test based on the optimal threshold
Time Frame: 12 months
Accuracy of the test assessed by Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value
12 months
Precision of the radiosensitivity predictive test
Time Frame: 12 months
Using the time dependant AUC (AUCt) method
12 months
Biological prognostics factors for capsular contracture occurence
Time Frame: 12 months
Number and type of different biological prognostic factors of capsular contracture occurence
12 months
Tumoral prognostics factors for capsular contracture occurence
Time Frame: 12 months
Number and type of different tumoral prognostic factors of capsular contracture occurence
12 months
Success of each surgical strategy in terms of deposit
Time Frame: 24 months
Number of deposit according to each reconstruction surgery (one or two step)
24 months
Cosmetic outcomes measure
Time Frame: 6, 12, 18 and 24 months
Cosmetic questionnaire : BREAST-Q
6, 12, 18 and 24 months
Functional outcomes measure
Time Frame: 6, 12, 18 and 24 months
Functional questionnaire: BREAST-Q
6, 12, 18 and 24 months
Patient satisfaction measure
Time Frame: 6, 12, 18 and 24 months
Patient satisfaction questionnaire: BREAST-Q
6, 12, 18 and 24 months
General quality of life measure
Time Frame: 6, 12, 18 and 24 months
Quality of life questionnaire: QLQ-C30
6, 12, 18 and 24 months
Specific quality of life measure for breast cancer patient
Time Frame: 6, 12, 18 and 24 months
Quality of life questionnaire for breast cancer patient: QLQ-BR23
6, 12, 18 and 24 months
Stability of the test after chemotherapy
Time Frame: 12 months
Test score at 12 months after the end of radiotherapy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Marian Gutowski, Institut Du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2019-07 PRE
  • 2019-A02178-49 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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