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

NCT ID: NCT04068623

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-04

Study Completion Date

2032-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Triple Negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Triple negative breast cancer

Blood sample

Intervention Type OTHER

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

Interventions

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Blood sample

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier DURANDO, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Locations

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Centre Jean PERRIN

Clermont-Ferrand, Please Select, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alexia GIRO

Role: CONTACT

0033473278005

Facility Contacts

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Alexia GIRO

Role: primary

0033473278005

References

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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.

Reference Type DERIVED
PMID: 33327268 (View on PubMed)

Other Identifiers

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2019-A01861-56

Identifier Type: -

Identifier Source: org_study_id

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