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NCT Number: NCT04438681

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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

  5. Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse

    Time frame: 8 years

    • Measurement of plasma ctDNA level

  6. Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse

    Time frame: 8 years

    • Time to metastatic relapse

  7. 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. Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors

    Time frame: 8 years

    • RNA expression of 6 genes of interest

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

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

Acronym: INSTIGO

Important dates

Study start
2020
Primary completion
2026
Study completion
2029
First posted
Jun 19, 2020
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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