Evaluating blood protein profiles to predict metastatic relapse in triple negative breast cancer
INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
Centre Jean Perrin · NCT04438681
This study is testing if certain blood proteins and other markers can help predict if patients with triple negative breast cancer will have a relapse after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Jean Perrin (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT04438681 on ClinicalTrials.gov |
What this trial studies
The INSTIGO study aims to assess the concentrations of plasma proteins at various stages of follow-up in patients with triple negative breast cancer to determine their predictive ability for metastatic relapse. Additionally, the study will explore other potential biomarkers, including Tumor-infiltrating Lymphocytes, circulating tumor DNA, and a tumor RNA signature. Blood samples will be collected before treatment and at multiple points during and after treatment to analyze these biomarkers. This approach seeks to provide a comprehensive understanding of factors influencing metastatic recurrence.
Who should consider this trial
Good fit: Ideal candidates are females over 18 years old diagnosed with non-metastatic, histologically confirmed triple negative breast cancer.
Not a fit: Patients who are unable to provide consent or are under guardianship will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved predictive tools for monitoring metastatic relapse in triple negative breast cancer patients.
How similar studies have performed: Other studies have shown promise in using blood-based biomarkers for cancer prognosis, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand
- Centre Jean PERRIN — Clermont-Ferrand, France (RECRUITING)
Study contacts
- Study coordinator: Hugo VEYSSIERE
- Email: hugo.veyssiere@clermont.unicancer.fr
- Phone: 0473278005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Triple Negative Breast Cancer