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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple negative breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 3 years (the period of recruitment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Women diagnosed and treated for non metastatic triple negative breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Xavier DURANDO, Pr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean PERRIN | Clermont-Ferrand | Please Select | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33327268 | Derived | 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. |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Plasma is collected in order to quantify the circulating tumor DNA at 1 year after the completion of radiation therapy and at the first metastatic recurrence
| 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) |
| 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) |
| 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 ctDNA and the metastatic relapse |
| 8 years |
| Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA) |
| 8 years |
| 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 |
| Relationship between platelet value and the presence of circulating tumor DNA (ctDNA) |
| 8 years |
| Relationship between NLR 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 all the blood parameters and the metastatic relapse |
| 8 years |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |