Triple Negative Breast CancerPERCEPTIONNCT04068623
Correlation Between TILs and Blood Cell Counts in Triple Negative Breast Cancer Patients
An observational study of Triple Negative Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Blood sample
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2019to Oct 2032
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women diagnosed and treated for non metastatic triple negative breast cancer
Who may be able to join
- Female
- Age > 18 years
- Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
- Patient treated with chemotherapy, surgery and radiation therapy
- Patient able to understand the French language
- Patient affiliated to social security
- Obtaining signed written consent
Who cannot join
- Male
- Unavailable tumoral samples before inclusion
- Unavailable blood test results at baseline, before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERCEPTION Trial Protocol: Comparison of Predictive and Prognostic Capacities of Neutrophil, Lymphocyte and Platelet Counts and Tumour-infiltrating Lymphocytes in Triple Negative Breast Cancer
The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.
Read the detailed description
Triple negative breast cancer (TNBC) is the most aggressive type of breast cancer. Because of the limited therapeutical strategies, early TNBC relapses are quite common during the five years following treatment.
It has been shown that the presence of tumor infiltrating lymphocytes (TILs) at baseline is related to good pathological response to neoadjuvant chemotherapy. In addition, the presence of a high quantity of TILs in the residual tumor after neoadjuvant chemotherapy is related to better survival rates.
Blood circulating elements, such as peripheral blood cells or circulating tumor DNA, could be of interest in predicting response to treatment and in the prediction of metastatic recurrences in different types of cancer, including breast cancer.
However, the correlation of these markers in triple negative breast cancer has not yet been thoroughly studied.
The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Blood sample
- Keywords
- Triple negative breast cancer, NLR (Neutrophil-to-Lymphocyte Ratio), TILs (Tumor Infiltrating Lymphocytes), Peripheral blood cells
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence
| Study group | Role | What they receive |
|---|---|---|
| Triple negative breast cancer | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the correlation between the lymphocyte infiltration rate assessed on biopsy, and the NLR (neutrophil-to-lymphocyte ratio) measured on blood samples, in women with triple negative breast cancer, at the time of diagnosis.
- The value of NLR at diagnosis;
- Tumor lymphocyte infiltration rate before treatment.
Measured: 3 years (the period of recruitment)
Secondary outcomes (12)
Assessment of the correlation between the TILs assessed on biopsy, and the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets and PLR (Platelet-to-Lymphocyte Ratio)), at the time of diagnosis.
- The values of leucocytes, lymphocytes, neutrophils, platelets and PLR at diagnosis;
- Tumor lymphocyte infiltration rate before treatment
Measured: 3 years (the period of recruitment)
Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the histological response to neo-adjuvant chemotherapy
- The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis;
- Histological response according to the Sataloff classification
Measured: 3 years (the period of recruitment)
Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the TILs at surgery specimen after neoadjuvant chemotherapy.
- The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis;
- Tumor lymphocyte infiltration rate at surgery specimen
Measured: 3 years (the period of recruitment)
Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) before surgery, and the lymphocyte infiltration rate at surgery after neoadjuvant chemotherapy.
- The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR before surgery;
- Tumor lymphocyte infiltration rate at surgery specimen
Measured: 3 years
Relationship between ctDNA and the metastatic relapse
- Measurement of plasma cDNA level
- Metastatic relapse
Measured: 8 years
Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA)
- The value of leucocytes
- Measurement of plasma cDNA level
Measured: 8 years
Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA)
- The value of lymphocytes
- Measurement of plasma cDNA level
Measured: 8 years
Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)
- The value of neutrophils
- Measurement of plasma cDNA level
Measured: 8 years
Relationship between platelet value and the presence of circulating tumor DNA (ctDNA)
- The value of platelets
- Measurement of plasma cDNA level
Measured: 8 years
Relationship between NLR value and the presence of circulating tumor DNA (ctDNA)
- The value of NLR
- Measurement of plasma cDNA level
Measured: 8 years
Relationship between PLR value and the presence of circulating tumor DNA (ctDNA)
- The value of PLR
- Measurement of plasma cDNA level
Measured: 8 years
Relationship between all the blood parameters and the metastatic relapse
- The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR
- Metastatic relapse
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start4 Dec 2019
- Primary completionOct 2027 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple Negative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DURANDO, Pr, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068623
- Sponsor's protocol ID
- 2019-A01861-56
- Acronym
- PERCEPTION
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2019
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lusho S, Durando X, Bidet Y, Molnar I, Kossai M, Bernadach M, Lacrampe N, Veyssiere H, Cavaille M, Gay-Bellile M, Radosevic-Robin N, Abrial C. PERCEPTION Trial protocol: Comparison of predictive and prognostic capacities of neutrophil, lymphocyte, and platelet counts and tumor-infiltrating lymphocytes in triple negative breast cancer. Medicine (Baltimore). 2020 Dec 11;99(50):e23418. doi: 10.1097/MD.0000000000023418.
PubMed 33327268
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERCEPTION Trial Protocol: Comparison of Predictive and Prognostic Capacities of Neutrophil, Lymphocyte and Platelet Counts and Tumour-infiltrating Lymphocytes in Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04068623
- Acronym / sponsor ID
- PERCEPTION / 2019-A01861-56
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Triple negative breast cancer, NLR (Neutrophil-to-Lymphocyte Ratio), TILs (Tumor Infiltrating Lymphocytes), Peripheral blood cells
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 28 Aug 2019 (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.
The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.
Detailed description
Triple negative breast cancer (TNBC) is the most aggressive type of breast cancer. Because of the limited therapeutical strategies, early TNBC relapses are quite common during the five years following treatment.
It has been shown that the presence of tumor infiltrating lymphocytes (TILs) at baseline is related to good pathological response to neoadjuvant chemotherapy. In addition, the presence of a high quantity of TILs in the residual tumor after neoadjuvant chemotherapy is related to better survival rates.
Blood circulating elements, such as peripheral blood cells or circulating tumor DNA, could be of interest in predicting response to treatment and in the prediction of metastatic recurrences in different types of cancer, including breast cancer.
However, the correlation of these markers in triple negative breast cancer has not yet been thoroughly studied.
The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple negative breast cancer | – | Other: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed and treated for non metastatic triple negative breast cancer
Key inclusion criteria (7 listed)
- Female
- Age > 18 years
- Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
- Patient treated with chemotherapy, surgery and radiation therapy
- Patient able to understand the French language
Key exclusion criteria (3 listed)
- Male
- Unavailable tumoral samples before inclusion
- Unavailable blood test results at baseline, before inclusion
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 |
|---|---|---|
| Blood sampleBlood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence | Other | Triple negative breast cancer |
Primary outcome
Assessment of the correlation between the lymphocyte infiltration rate assessed on biopsy, and the NLR (neutrophil-to-lymphocyte ratio) measured on blood samples, in women with triple negative breast cancer, at the time of diagnosis.
Time frame: 3 years (the period of recruitment)
* The value of NLR at diagnosis; * Tumor lymphocyte infiltration rate before treatment.
12 secondary outcomes
Assessment of the correlation between the TILs assessed on biopsy, and the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets and PLR (Platelet-to-Lymphocyte Ratio)), at the time of diagnosis.
Time frame: 3 years (the period of recruitment)
Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the histological response to neo-adjuvant chemotherapy
Time frame: 3 years (the period of recruitment)
Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the TILs at surgery specimen after neoadjuvant chemotherapy.
Time frame: 3 years (the period of recruitment)
Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) before surgery, and the lymphocyte infiltration rate at surgery after neoadjuvant chemotherapy.
Time frame: 3 years
Relationship between ctDNA and the metastatic relapse
Time frame: 8 years
Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA)
Time frame: 8 years
Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA)
Time frame: 8 years
Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)
Time frame: 8 years
Relationship between platelet value and the presence of circulating tumor DNA (ctDNA)
Time frame: 8 years
Relationship between NLR value and the presence of circulating tumor DNA (ctDNA)
Time frame: 8 years
Relationship between PLR value and the presence of circulating tumor DNA (ctDNA)
Time frame: 8 years
Relationship between all the blood parameters and the metastatic relapse
Time frame: 8 years
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 20 Mar 2026.
- Derived from this study: PubMed 33327268Lusho S, Durando X, Bidet Y, Molnar I, Kossai M, Bernadach M, Lacrampe N, Veyssiere H, Cavaille M, Gay-Bellile M, Radosevic-Robin N, Abrial C. PERCEPTION Trial protocol: Comparison of predictive and prognostic capacities of neutrophil, lymphocyte, and platelet counts and tumor-infiltrating lymphocytes in triple negative breast cancer. Medicine (Baltimore). 2020 Dec 11;99(50):e23418. doi: 10.1097/MD.0000000000023418.
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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. This study is not recruiting at the moment.
Xavier DURANDO, Pr principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer, run by Centre Jean Perrin at 1 site 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the correlation between the lymphocyte infiltration rate assessed on biopsy, and the NLR (neutrophil-to-lymphocyte ratio) measured on blood samples, in women with triple negative breast cancer, at the time of diagnosis. (time frame: 3 years (the period of recruitment)). 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 NCT04068623, which also lists 1 linked publication.
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 20 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.