Breast CancerPRETORIANCT04342546
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
A study testing NovaGray RILA Breast® test in people with Breast Cancer and Capsular Contracture Associated With Breast Implant, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Breast Cancer, Capsular Contracture Associated With Breast Implant
- What is being tested?
- NovaGray RILA Breast® test
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 9 sitesFrance
- Study dates
- 11 Dec 2020to 10 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Centre Georges François Leclerc
Dijon, 21079
Laura VINCENT, lvincent@cgfl.fr
- Recruiting
Centre Oscar Lambret
Lille, 59000
Marie Pierre Chauvet, mp-chauvet@o-lambret.fr
- Recruiting
Centre Léon Bérard
Lyon, 69373
Marie-Adele Dammacco, marie-adele.dammacco@lyon.unicancer.fr
- Recruiting
Institut Paoli Calmette
Marseille, 13009
Marie Bannier, bannierm@ipc.unicancer.fr
- Recruiting
Institut du Cancer de Montpellier
Montpellier, 34298
Marian Gutowski, marian.gutowski@icm.unicancer.fr
- Recruiting
centre Antoine Lacassagne
Nice, 06189
Maud DUQUESNE, maud.duquesne@nice.unicancer.fr
- Recruiting
Hôpital Tenon
Paris, 75970
Michael Atlan, michael.atlan@aphp.fr
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Victoire Brillaud-Meflah, victoire.brillaud-meflah@ico.unicancer.fr
- Recruiting
Institut Claudius Regaud
Toulouse, 31059
Carole MASSABEAU, massabeau.carole@iuct-oncopole.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- NovaGray RILA Breast® test
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaGray RILA Breast® testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Toxicity test | Experimental | 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 Receives: Device: NovaGray RILA Breast® test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of a radiosensitivity test to predict capsular contracture
To identify the Area Under the Curve (AUC) of the radiosensitive predictive test of Grade 3-4 capsular contracture
Measured: 12 months after the end of radiotherapy
Secondary outcomes (12)
Capsular contracture prevalence
Rate of capsular contracture after radiotherapy
Measured: 12 Months
Accuracy of the dichotomized test based on the optimal threshold
Accuracy of the test assessed by Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value
Measured: 12 months
Precision of the radiosensitivity predictive test
Using the time dependant AUC (AUCt) method
Measured: 12 months
Biological prognostics factors for capsular contracture occurence
Number and type of different biological prognostic factors of capsular contracture occurence
Measured: 12 months
Tumoral prognostics factors for capsular contracture occurence
Number and type of different tumoral prognostic factors of capsular contracture occurence
Measured: 12 months
Success of each surgical strategy in terms of deposit
Number of deposit according to each reconstruction surgery (one or two step)
Measured: 24 months
Cosmetic outcomes measure
Cosmetic questionnaire : BREAST-Q
Measured: 6, 12, 18 and 24 months
Functional outcomes measure
Functional questionnaire: BREAST-Q
Measured: 6, 12, 18 and 24 months
Patient satisfaction measure
Patient satisfaction questionnaire: BREAST-Q
Measured: 6, 12, 18 and 24 months
General quality of life measure
Quality of life questionnaire: QLQ-C30
Measured: 6, 12, 18 and 24 months
Specific quality of life measure for breast cancer patient
Quality of life questionnaire for breast cancer patient: QLQ-BR23
Measured: 6, 12, 18 and 24 months
Stability of the test after chemotherapy
Test score at 12 months after the end of radiotherapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start11 Dec 2020
- Primary completion10 Dec 2029 (estimated)
- Study completion10 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marian Gutowski, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342546
- Sponsor's protocol ID
- PROICM 2019-07 PRE
- Other IDs
- 2019-A02178-49
- Acronym
- PRETORIA
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Negre G, Balcaen T, Dast S, Sinna R, Chazard E. Breast reconstruction in France, observational study of 140,904 cases of mastectomy for breast cancer. Ann Chir Plast Esthet. 2020 Feb;65(1):36-43. doi: 10.1016/j.anplas.2019.07.014. Epub 2019 Aug 2.
PubMed 31383624Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242.
PubMed 25003439Howes BH, Watson DI, Xu C, Fosh B, Canepa M, Dean NR. Quality of life following total mastectomy with and without reconstruction versus breast-conserving surgery for breast cancer: A case-controlled cohort study. J Plast Reconstr Aesthet Surg. 2016 Sep;69(9):1184-91. doi: 10.1016/j.bjps.2016.06.004. Epub 2016 Jun 18.
PubMed 27406255Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
PubMed 15894097Ricci JA, Epstein S, Momoh AO, Lin SJ, Singhal D, Lee BT. A meta-analysis of implant-based breast reconstruction and timing of adjuvant radiation therapy. J Surg Res. 2017 Oct;218:108-116. doi: 10.1016/j.jss.2017.05.072. Epub 2017 Jun 15.
PubMed 28985836Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20.
PubMed 21336948
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction
- ClinicalTrials.gov ID
- NCT04342546
- Acronym / sponsor ID
- PRETORIA / PROICM 2019-07 PRE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 10 Dec 2029 (estimated)
- Study completion
- 10 Dec 2031 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Toxicity test | Experimental | Device: NovaGray RILA Breast® testFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovaGray RILA Breast® testThe 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. | Device | Toxicity test |
Primary outcome
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 secondary outcomes
Capsular contracture prevalence
Time frame: 12 Months
Accuracy of the dichotomized test based on the optimal threshold
Time frame: 12 months
Precision of the radiosensitivity predictive test
Time frame: 12 months
Biological prognostics factors for capsular contracture occurence
Time frame: 12 months
Tumoral prognostics factors for capsular contracture occurence
Time frame: 12 months
Success of each surgical strategy in terms of deposit
Time frame: 24 months
Cosmetic outcomes measure
Time frame: 6, 12, 18 and 24 months
Functional outcomes measure
Time frame: 6, 12, 18 and 24 months
Patient satisfaction measure
Time frame: 6, 12, 18 and 24 months
General quality of life measure
Time frame: 6, 12, 18 and 24 months
Specific quality of life measure for breast cancer patient
Time frame: 6, 12, 18 and 24 months
Stability of the test after chemotherapy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 31383624Negre G, Balcaen T, Dast S, Sinna R, Chazard E. Breast reconstruction in France, observational study of 140,904 cases of mastectomy for breast cancer. Ann Chir Plast Esthet. 2020 Feb;65(1):36-43. doi: 10.1016/j.anplas.2019.07.014. Epub 2019 Aug 2.
- Background: PubMed 25003439Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242.
- Background: PubMed 27406255Howes BH, Watson DI, Xu C, Fosh B, Canepa M, Dean NR. Quality of life following total mastectomy with and without reconstruction versus breast-conserving surgery for breast cancer: A case-controlled cohort study. J Plast Reconstr Aesthet Surg. 2016 Sep;69(9):1184-91. doi: 10.1016/j.bjps.2016.06.004. Epub 2016 Jun 18.
- Background: PubMed 15894097Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
- Background: PubMed 28985836Ricci JA, Epstein S, Momoh AO, Lin SJ, Singhal D, Lee BT. A meta-analysis of implant-based breast reconstruction and timing of adjuvant radiation therapy. J Surg Res. 2017 Oct;218:108-116. doi: 10.1016/j.jss.2017.05.072. Epub 2017 Jun 15.
- Results publication: PubMed 21336948Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marian Gutowski study chair
Institut du Cancer de Montpellier - Val d'Aurelle
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovaGray RILA Breast® test in people with Breast Cancer and Capsular Contracture Associated With Breast Implant, run by Institut du Cancer de Montpellier - Val d'Aurelle at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore MOUSSION (04 67 61 31 02 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of a radiosensitivity test to predict capsular contracture (time frame: 12 months after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342546, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.