Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients

Triple Negative Breast Cancer Clinical Trial

— INSTIGO  

Official title:

INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438681
• Other study ID #: 2020-A01423-36
• Status: Recruiting
• Start date: November 27, 2020
• Est. completion date: November 9, 2029

Study information

• Verified date: May 2024
• Source: Centre Jean Perrin
• Contact: Hugo VEYSSIERE
• Phone: 0473278005
• Email: hugo.veyssiere[@]clermont.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.

Description:

The investigators propose to carry out a study that measures the concentrations of a set of plasma proteins in order to assess their ability to predict metastatic relapse of triple negative breast cancer. A plasma protein profile could be an interesting biomarker since it is easily accessible and quantifiable.

The investigators also propose to search relation between metastatic relapse in TNBC and other biomarkers or potential biomarkers such as Tumor-infiltrating Lymphocytes (TILs), figurative blood components and circulating tumour DNA (ctDNA).

Finally, they also want to validate a TNBC RNA signature, established at Jean PERRIN Center, by analyzing the RNA expression of 8 genes.

Before treatment begins, the patient will take an initial blood sample. A second blood sample will be taken on the day of the first surgery or the day of the surgery post chemotherapy. A third blood sample will be done on the day of the beginning of the radiotherapy. A 4th and a 5th blood sample will be done at 6 months and 1 year respectively after the end of the radiotherapy. A part of these blood samples will be used for the quantification of circulating proteins, for the determination of the blood's figurative elements and for the quantification of circulating tumour DNA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 9, 2029
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: No
• 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 able to understand the French language

• Patient affiliated to social security

• Obtaining signed written consent

Exclusion Criteria:

• Persons deprived of their freedom or under guardianship or incapable of giving consent

• Refusal to participate

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Centre Jean PERRIN	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)	- Plasma concentrations of a set of proteins at diagnosis (measured in g/L)	8 years
Primary	Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)	- Time to metastatic relapse	8 years
Secondary	Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy	- Plasma concentrations of a set of proteins (measured in g/L)	8 years
Secondary	Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy	- Time to metastatic relapse	8 years
Secondary	Identification of a characteristic plasma protein profile at the time of metastatic relapse	- Plasma concentrations of a set of proteins (measured in g/L)	8 years
Secondary	Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.	- Tumor lymphocyte infiltration rate before treatment	8 years
Secondary	Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse	- Measurement of plasma ctDNA level	8 years
Secondary	Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse	- Time to metastatic relapse	8 years
Secondary	Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse	- The values of NLR and PLR at diagnosis (no Unit)	8 years
Secondary	Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors	- RNA expression of 6 genes of interest	8 years
Secondary	Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy	- Plasma concentrations of a set of proteins at diagnosis	3 years and 6 months
Secondary	Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy	- Histological response according to the Sataloff classification	3 years and 6 months
Secondary	Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .	- Tumor lymphocyte infiltration rate before treatment	3 years and 6 months
Secondary	Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy	The values of NLR and PLR at diagnosis; The values of NLR and PLR after neoadjuvant chemotherapy	3 years and 6 months