PERCEPTION Trial Protocol: Comparison of Predictive and Prognostic Capacities of Neutrophil, Lymphocyte and Platelet Counts and Tumour-infiltrating Lymphocytes in Triple Negative Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Unavailable tumoral samples before inclusion
- •Unavailable blood test results at baseline, before inclusion
Outcomes
Primary Outcomes
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.
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.(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(3 years (the period of recruitment))
- Relationship between NLR value and the presence of circulating tumor DNA (ctDNA)(8 years)
- 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.(3 years)
- Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA)(8 years)
- Relationship between platelet value and the presence of circulating tumor DNA (ctDNA)(8 years)
- Relationship between PLR value and the presence of circulating tumor DNA (ctDNA)(8 years)
- Relationship between ctDNA and the metastatic relapse(8 years)
- Relationship between all the blood parameters and the metastatic relapse(8 years)
- 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.(3 years (the period of recruitment))
- Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA)(8 years)
- Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)(8 years)