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

February 13, 2024 updated by: Centre Jean Perrin

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
Time Frame: 8 years
- Plasma concentrations of a set of proteins at diagnosis (measured in g/L)
8 years
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
Time Frame: 8 years
- Time to metastatic relapse
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Frame: 8 years
- Plasma concentrations of a set of proteins (measured in g/L)
8 years
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 Frame: 8 years
- Time to metastatic relapse
8 years
Identification of a characteristic plasma protein profile at the time of metastatic relapse
Time Frame: 8 years
- Plasma concentrations of a set of proteins (measured in g/L)
8 years
Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.
Time Frame: 8 years
- Tumor lymphocyte infiltration rate before treatment
8 years
Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
Time Frame: 8 years
- Measurement of plasma ctDNA level
8 years
Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse
Time Frame: 8 years
- Time to metastatic relapse
8 years
Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse
Time Frame: 8 years
- The values of NLR and PLR at diagnosis (no Unit)
8 years
Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors
Time Frame: 8 years
- RNA expression of 6 genes of interest
8 years
Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
Time Frame: 3 years and 6 months
- Plasma concentrations of a set of proteins at diagnosis
3 years and 6 months
Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy
Time Frame: 3 years and 6 months
- Histological response according to the Sataloff classification
3 years and 6 months
Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .
Time Frame: 3 years and 6 months
- Tumor lymphocyte infiltration rate before treatment
3 years and 6 months
Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy
Time Frame: 3 years and 6 months
  • The values of NLR and PLR at diagnosis
  • The values of NLR and PLR after neoadjuvant chemotherapy
3 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2020

Primary Completion (Estimated)

November 9, 2024

Study Completion (Estimated)

November 9, 2029

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01423-36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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