- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068623
Correlation Between TILs and Blood Cell Counts in Triple Negative Breast Cancer Patients (PERCEPTION)
PERCEPTION Trial Protocol: Comparison of Predictive and Prognostic Capacities of Neutrophil, Lymphocyte and Platelet Counts and Tumour-infiltrating Lymphocytes in Triple Negative Breast Cancer
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Please Select
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Clermont-Ferrand, Please Select, France, 63000
- Recruiting
- Centre Jean Perrin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Triple negative breast cancer
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Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence
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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)
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|
3 years (the period of recruitment)
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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)
|
|
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)
|
|
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)
|
|
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
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|
3 years
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Relationship between ctDNA and the metastatic relapse
Time Frame: 8 years
|
|
8 years
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Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA)
Time Frame: 8 years
|
|
8 years
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Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA)
Time Frame: 8 years
|
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8 years
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Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)
Time Frame: 8 years
|
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8 years
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Relationship between platelet value and the presence of circulating tumor DNA (ctDNA)
Time Frame: 8 years
|
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8 years
|
Relationship between NLR value and the presence of circulating tumor DNA (ctDNA)
Time Frame: 8 years
|
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8 years
|
Relationship between PLR value and the presence of circulating tumor DNA (ctDNA)
Time Frame: 8 years
|
|
8 years
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Relationship between all the blood parameters and the metastatic relapse
Time Frame: 8 years
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|
8 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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