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NCT Number: NCT04068623

Correlation Between TILs and Blood Cell Counts in Triple Negative Breast Cancer Patients

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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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Jean PERRIN

Clermont-Ferrand, Please Select, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence

Primary outcomes

  1. 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

  1. 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)

    • The values of leucocytes, lymphocytes, neutrophils, platelets and PLR at diagnosis;
    • Tumor lymphocyte infiltration rate before treatment

  2. 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)

    • The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis;
    • Histological response according to the Sataloff classification

  3. 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)

    • The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis;
    • Tumor lymphocyte infiltration rate at surgery specimen

  4. 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

    • The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR before surgery;
    • Tumor lymphocyte infiltration rate at surgery specimen

  5. Relationship between ctDNA and the metastatic relapse

    Time frame: 8 years

    • Measurement of plasma cDNA level
    • Metastatic relapse

  6. Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA)

    Time frame: 8 years

    • The value of leucocytes
    • Measurement of plasma cDNA level

  7. Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA)

    Time frame: 8 years

    • The value of lymphocytes
    • Measurement of plasma cDNA level

  8. Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)

    Time frame: 8 years

    • The value of neutrophils
    • Measurement of plasma cDNA level

  9. Relationship between platelet value and the presence of circulating tumor DNA (ctDNA)

    Time frame: 8 years

    • The value of platelets
    • Measurement of plasma cDNA level

  10. Relationship between NLR value and the presence of circulating tumor DNA (ctDNA)

    Time frame: 8 years

    • The value of NLR
    • Measurement of plasma cDNA level

  11. Relationship between PLR value and the presence of circulating tumor DNA (ctDNA)

    Time frame: 8 years

    • The value of PLR
    • Measurement of plasma cDNA level

  12. Relationship between all the blood parameters and the metastatic relapse

    Time frame: 8 years

    • The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR
    • Metastatic relapse

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study 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

Acronym: PERCEPTION

Important dates

Study start
2019
Primary completion
2027
Study completion
2032
First posted
Aug 28, 2019
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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