NCT03436069

Brief Summary

Candidate markers have been identified thanks to an original approach developed by our research team aiming at detecting ectopic gene expression using public pan-genomic breast cancer data. The same approach had already been used and validated in lung tumors, leukemias and lymphomas. The main objective of the present research is to use tumor samples from patients in a retrospective and prospective cohort to test and validate the relevance of these prognostic markers in breast cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress67%
Jan 2011Dec 2033

Study Start

First participant enrolled

January 1, 2011

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
15.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

23 years

First QC Date

December 14, 2017

Last Update Submit

February 27, 2023

Conditions

Keywords

Breast cancerbiomarkersprognosticectopic gene expressionexpression profiletissue-specific genesresponse to treatment

Outcome Measures

Primary Outcomes (1)

  • Study of ectopic gene expression to define new prognostic biomarkers in breast cancer

    The overall survival and disease-free survival of patient with breast cancers will be analyzed in terms of gene expression change in order to identify new prognostic biomarkers.

    12 years, with evaluation every 3 years

Secondary Outcomes (1)

  • Study of response to neoadjuvant treatments of breast cancer assessed from anatomopathological data.

    12 years, with evaluation every 3 years

Interventions

Eligibility Criteria

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

Adult female patients with breast cancer

You may qualify if:

  • Adult female patients with breast cancer

You may not qualify if:

  • Presence of another cancer, excluding basal cell cancers or pre-neoplastic lesions of the cervix.
  • Subject under guardianship or subject deprived of liberty
  • Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.)
  • Male patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anne-Cécile PHILIPPE

Grenoble, 38043, France

RECRUITING

Related Publications (5)

  • Wang J, Mi JQ, Debernardi A, Vitte AL, Emadali A, Meyer JA, Charmpi K, Ycart B, Callanan MB, Carroll WL, Khochbin S, Rousseaux S. A six gene expression signature defines aggressive subtypes and predicts outcome in childhood and adult acute lymphoblastic leukemia. Oncotarget. 2015 Jun 30;6(18):16527-42. doi: 10.18632/oncotarget.4113.

    PMID: 26001296BACKGROUND
  • Le Bescont A, Vitte AL, Debernardi A, Curtet S, Buchou T, Vayr J, de Reynies A, Ito A, Guardiola P, Brambilla C, Yoshida M, Brambilla E, Rousseaux S, Khochbin S. Receptor-Independent Ectopic Activity of Prolactin Predicts Aggressive Lung Tumors and Indicates HDACi-Based Therapeutic Strategies. Antioxid Redox Signal. 2015 Jul 1;23(1):1-14. doi: 10.1089/ars.2013.5581. Epub 2014 Mar 6.

    PMID: 24512221BACKGROUND
  • Emadali A, Rousseaux S, Bruder-Costa J, Rome C, Duley S, Hamaidia S, Betton P, Debernardi A, Leroux D, Bernay B, Kieffer-Jaquinod S, Combes F, Ferri E, McKenna CE, Petosa C, Bruley C, Garin J, Ferro M, Gressin R, Callanan MB, Khochbin S. Identification of a novel BET bromodomain inhibitor-sensitive, gene regulatory circuit that controls Rituximab response and tumour growth in aggressive lymphoid cancers. EMBO Mol Med. 2013 Aug;5(8):1180-95. doi: 10.1002/emmm.201202034. Epub 2013 Jul 4.

    PMID: 23828858BACKGROUND
  • Rousseaux S, Debernardi A, Jacquiau B, Vitte AL, Vesin A, Nagy-Mignotte H, Moro-Sibilot D, Brichon PY, Lantuejoul S, Hainaut P, Laffaire J, de Reynies A, Beer DG, Timsit JF, Brambilla C, Brambilla E, Khochbin S. Ectopic activation of germline and placental genes identifies aggressive metastasis-prone lung cancers. Sci Transl Med. 2013 May 22;5(186):186ra66. doi: 10.1126/scitranslmed.3005723.

    PMID: 23698379BACKGROUND
  • Reynoird N, Schwartz BE, Delvecchio M, Sadoul K, Meyers D, Mukherjee C, Caron C, Kimura H, Rousseaux S, Cole PA, Panne D, French CA, Khochbin S. Oncogenesis by sequestration of CBP/p300 in transcriptionally inactive hyperacetylated chromatin domains. EMBO J. 2010 Sep 1;29(17):2943-52. doi: 10.1038/emboj.2010.176. Epub 2010 Jul 30.

    PMID: 20676058BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The research uses blood samples and biopsies made at diagnosis or during surgical resection of the tumor for gene or protein expression analysis (RNA and protein extraction).

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anne-Cécile PHILIPPE, Dr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR
  • Mireille MOUSSEAU, Pr

    Grenoble Alpes University Hospital

    STUDY DIRECTOR

Central Study Contacts

Anne-Cécile PHILIPPE, Dr

CONTACT

Emmanuelle JACQUET, Dr

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 14, 2017

First Posted

February 19, 2018

Study Start

January 1, 2011

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations