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

Triple Negative Breast Cancer Clinical Trial

— PERCEPTION  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068623
• Other study ID #: 2019-A01861-56
• Status: Recruiting
• Start date: December 4, 2019
• Est. completion date: October 2027

Study information

• Verified date: June 2024
• Source: Centre Jean Perrin
• Contact: Alexia GIRO
• Phone: 0033473278005
• Email: alexia.giro[@]clermont.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2027
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Jean PERRIN	Clermont-Ferrand	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The values of leucocytes, lymphocytes, neutrophils, platelets and PLR at diagnosis; Tumor lymphocyte infiltration rate before treatment	3 years (the period of recruitment)
Secondary	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	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)
Secondary	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.	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)
Secondary	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.	The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR before surgery; Tumor lymphocyte infiltration rate at surgery specimen	3 years
Secondary	Relationship between ctDNA and the metastatic relapse	Measurement of plasma cDNA level; Metastatic relapse	8 years
Secondary	Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA)	The value of leucocytes; Measurement of plasma cDNA level	8 years
Secondary	Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA)	The value of lymphocytes; Measurement of plasma cDNA level	8 years
Secondary	Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)	The value of neutrophils; Measurement of plasma cDNA level	8 years
Secondary	Relationship between platelet value and the presence of circulating tumor DNA (ctDNA)	The value of platelets; Measurement of plasma cDNA level	8 years
Secondary	Relationship between NLR value and the presence of circulating tumor DNA (ctDNA)	The value of NLR; Measurement of plasma cDNA level	8 years
Secondary	Relationship between PLR value and the presence of circulating tumor DNA (ctDNA)	The value of PLR; Measurement of plasma cDNA level	8 years
Secondary	Relationship between all the blood parameters and the metastatic relapse	The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR; Metastatic relapse	8 years