Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 66 for:    PRETORIA | Breast Cancer
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342546
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Capsular Contracture Associated With Breast Implant Device: NovaGray RILA Breast® test Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: For all the 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Capsular contracture prevalence [ Time Frame: 12 Months ]
    Rate of capsular contracture after radiotherapy

  2. 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

  3. Precision of the radiosensitivity predictive test [ Time Frame: 12 months ]
    Using the time dependant AUC (AUCt) method

  4. Biological prognostics factors for capsular contracture occurence [ Time Frame: 12 months ]
    Number and type of different biological prognostic factors of capsular contracture occurence

  5. Tumoral prognostics factors for capsular contracture occurence [ Time Frame: 12 months ]
    Number and type of different tumoral prognostic factors of capsular contracture occurence

  6. 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)

  7. Cosmetic outcomes measure [ Time Frame: 6, 12, 18 and 24 months ]
    Cosmetic questionnaire : BREAST-Q

  8. Functional outcomes measure [ Time Frame: 6, 12, 18 and 24 months ]
    Functional questionnaire: BREAST-Q

  9. Patient satisfaction measure [ Time Frame: 6, 12, 18 and 24 months ]
    Patient satisfaction questionnaire: BREAST-Q

  10. General quality of life measure [ Time Frame: 6, 12, 18 and 24 months ]
    Quality of life questionnaire: QLQ-C30

  11. 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

  12. Stability of the test after chemotherapy [ Time Frame: 12 months ]
    Test score at 12 months after the end of radiotherapy


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients with breast cancer treated by mastectomy with immediate implant breast reconstruction
Accepts Healthy Volunteers:   No
Criteria

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 or women of childbearing potential unwilling to employ adequate contraception
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342546


Contacts
Layout table for location contacts
Contact: Aurore MOUSSION 04 67 61 31 02 ext +33 DRCI-icm105@icm.unicancer.fr
Contact: Emmanuelle TEXIER 04 67 61 31 02 ext +33 DRCI-icm105@icm.unicancer.fr

Locations
Layout table for location information
France
Centre Oscar Lambret Recruiting
Lille, France, 59000
Contact: Marie Pierre Chauvet       mp-chauvet@o-lambret.fr   
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Marie-Adele Dammacco       marie-adele.dammacco@lyon.unicancer.fr   
Institut Paoli Calmette Recruiting
Marseille, France, 13009
Contact: Marie Bannier       bannierm@ipc.unicancer.fr   
Institut du Cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: Marian Gutowski       marian.gutowski@icm.unicancer.fr   
centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Maud DUQUESNE       maud.duquesne@nice.unicancer.fr   
Hôpital Tenon Recruiting
Paris, France, 75970
Contact: Michael Atlan       michael.atlan@aphp.fr   
Institut de Cancérologie de l'Ouest Recruiting
Saint-Herblain, France, 44805
Contact: Victoire Brillaud-Meflah       victoire.brillaud-meflah@ico.unicancer.fr   
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Contact: Carole MASSABEAU       massabeau.carole@iuct-oncopole.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Study Chair: Marian Gutowski Institut du Cancer de Montpellier
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04342546    
Other Study ID Numbers: PROICM 2019-07 PRE
2019-A02178-49 ( Registry Identifier: ID-RCB )
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases