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

March 18, 2026 updated by: Centre Jean Perrin

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Please Select
      • Clermont-Ferrand, Please Select, France, 63000
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Women diagnosed and treated for non metastatic triple negative breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Triple negative breast cancer
Other: Blood sample
Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 3 years (the period of recruitment)
  • The value of NLR at diagnosis;
  • Tumor lymphocyte infiltration rate before treatment.
3 years (the period of recruitment)

Secondary Outcome Measures

Outcome Measure
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.
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
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)
  • The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis;
  • Histological response according to the Sataloff classification
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)
  • The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis;
  • Tumor lymphocyte infiltration rate at surgery specimen
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
  • The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR before surgery;
  • Tumor lymphocyte infiltration rate at surgery specimen
3 years
Relationship between ctDNA and the metastatic relapse
Time Frame: 8 years
  • Measurement of plasma cDNA level
  • Metastatic relapse
8 years
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
8 years
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 years
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
8 years
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
8 years
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
8 years
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
8 years
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
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Investigators

  • Principal Investigator: Xavier DURANDO, Pr, Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2019

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2032

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A01861-56

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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