Clinical trial NCT04068623: Correlation Between TILs and Blood Cell Counts in Triple Negative Breast Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Triple Negative Breast Cancer
Keywords: Triple negative breast cancer
NLR (Neutrophil-to-Lymphocyte Ratio)
TILs (Tumor Infiltrating Lymphocytes)
Peripheral blood cells
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed and treated for non metastatic triple negative breast cancer

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Male
* Unavailable tumoral samples before inclusion
* Unavailable blood test results at baseline, before inclusion

Primary outcomes:
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.
timeFrame: 3 years (the period of recruitment)
Secondary outcomes:
measure: 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.
timeFrame: 3 years (the period of recruitment)
measure: 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
timeFrame: 3 years (the period of recruitment)
measure: 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.
timeFrame: 3 years (the period of recruitment)
measure: 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.
timeFrame: 3 years
measure: Relationship between ctDNA and the metastatic relapse
timeFrame: 8 years
measure: Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA)
timeFrame: 8 years
measure: Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA)
timeFrame: 8 years
measure: Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)
timeFrame: 8 years
measure: Relationship between platelet value and the presence of circulating tumor DNA (ctDNA)
timeFrame: 8 years
measure: Relationship between NLR value and the presence of circulating tumor DNA (ctDNA)
timeFrame: 8 years
measure: Relationship between PLR value and the presence of circulating tumor DNA (ctDNA)
timeFrame: 8 years
measure: Relationship between all the blood parameters and the metastatic relapse
timeFrame: 8 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
state: Please Select
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.