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

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ClinicalTrials.gov Identifier: NCT04068623
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin

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.

Condition or disease Intervention/treatment
Triple Negative Breast Cancer Other: Blood sample

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Figured Blood Elements and Tumor Lymphocyte Infiltration Rate in Patients With Triple-Negative Breast Cancer
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women diagnosed and treated for non metastatic triple negative breast cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068623


Contacts
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Contact: Sejdi LUSHO 0033463663337 sejdi.lusho@clermont.unicancer.fr

Locations
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France
Centre Jean PERRIN Recruiting
Clermont-Ferrand, Please Select, France, 63000
Contact: Sejdi LUSHO    0033463663337    sejdi.lusho@clermont.unicancer.fr   
Principal Investigator: Xavier DURANDO         
Sponsors and Collaborators
Centre Jean Perrin
Investigators
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Principal Investigator: Xavier DURANDO, Pr Centre Jean Perrin
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Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT04068623    
Other Study ID Numbers: 2019-A01861-56
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Jean Perrin:
Triple negative breast cancer
NLR (Neutrophil-to-Lymphocyte Ratio)
TILs (Tumor Infiltrating Lymphocytes)
Peripheral blood cells
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases