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

NCT04068623 | Active Not Recruiting

• 1 other identifier: 2019-A01861-56
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Keywords

Triple negative breast cancer; NLR (Neutrophil-to-Lymphocyte Ratio); TILs (Tumor Infiltrating Lymphocytes); Peripheral blood cells

Outcome Measures

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.

  * The value of NLR at diagnosis; * Tumor lymphocyte infiltration rate before treatment.

  3 years (the period of recruitment)

Secondary Outcomes (12)

• 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)

• 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

Study Arms (1)

Triple negative breast cancer

Other: Blood sample

Interventions

Blood sample OTHER

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

Triple negative breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women diagnosed and treated for non metastatic triple negative breast cancer

You may qualify if:

• 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

You may not qualify if:

• Male

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean PERRIN

Clermont-Ferrand, Please Select, 63000, France

Location

Related Publications (1)

• 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.

  PMID: 33327268 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xavier DURANDO, Pr

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 28, 2019
• Study Start: December 4, 2019
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (1)