NCT04438681

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
43mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Nov 2020Nov 2029

First Submitted

Initial submission to the registry

June 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 27, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2029

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

6 years

First QC Date

June 15, 2020

Last Update Submit

November 27, 2025

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (12)

  • 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

    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

    8 years

  • Identification of a characteristic plasma protein profile at the time of metastatic relapse

    8 years

  • Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.

    8 years

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

    8 years

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

Location

Related Publications (2)

  • Pinard C, Ginzac A, Molnar I, Veyssiere H, Bidet Y, Sapin V, Durif J, Abrial C, Penault-Llorca F, Durando X, Radosevic-Robin N. Identification of serum proteins associated with response of triple-negative breast cancer to neoadjuvant chemotherapy: preliminary results from the INSTIGO trial. Clin Proteomics. 2025 Dec 29;22(1):50. doi: 10.1186/s12014-025-09574-0.

    PMID: 41462069DERIVED

  • Veyssiere H, Lusho S, Molnar I, Kossai M, Bernadach M, Abrial C, Bidet Y, Radosevic-Robin N, Durando X. INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse of Triple Negative Breast Cancer. Front Oncol. 2021 Jun 25;11:653370. doi: 10.3389/fonc.2021.653370. eCollection 2021.

    PMID: 34249690DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 19, 2020

Study Start

November 27, 2020

Primary Completion (Estimated)

November 9, 2026

Study Completion (Estimated)

November 9, 2029

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations

FR(1)