RNA and Heat Shock Protein Biomarkers in Radiation-induced Fibrosis in Breast Cancer

NCT03000764 | Completed

• 1 other identifier: 2016-A00592-49
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to seeking a molecular signature of pathological radiation induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two groups of patients distinguished by their individual radiosensitivity. The signature will integrate recent insights in terms of alternative splicing of mRNAs and level of expression of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In each group each expression patterns of candidate HSP proteins potentially predictive of pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on cell culture will be characterized.

Conditions

Breast Carcinoma; Fibrosis

Keywords

Skin biopsy; Radiotherapy; RNA biomarker; HSP biomarker; Exon junction array; Gene expression; Radiosensitivity prediction

Outcome Measures

Primary Outcomes (1)

• Global mRNA alternative splicing and expression of non-coding RNAs profiles in healthy dermal fibroblasts

  frequency of inclusion of individual exons within the set of mRNA isoforms (overall splicing profile) and variation in expression of non-coding RNAs

  6 months

Secondary Outcomes (8)

• Transcriptomic signature of pathological induced fibrosis when comparing the primary outcome between the two populations on cultured fibroblasts

  6 months

• Transcriptomic signature of pathological induced fibrosis when comparing the primary outcome between the two populations on serum

  6 months

• Individual radiosensitivity on healthy dermal fibroblasts

  6 months

• Comparison of the overall mRNA splicing and non-coding RNA expression profiles between non irradiated and irradiated dermal fibroblasts in the same individual

  6 months

• Changes in cellular distribution of the main non-coding RNAs whose expression varies significantly within the pre-identified signature between the 2 groups of patients

  6 months

Study Arms (1)

Biomarkers

EXPERIMENTAL

Other: skin biopsies; Other: blood samples

Interventions

skin biopsies OTHER

Biopsies (12 G) will be performed : * in non-irradiated breast skin * in irradiated breast skin

Biomarkers

blood samples OTHER

blood samples are collected: * 10 ml in EDTA tube * 2,5 ml in PAXgene Blood RNA tube * 4 ml in EDTA tube

Biomarkers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women
• age ≥ 18 and \<70 years old
• non metastatic disease
• ECOG performance status 0 or 1
• chest size ≤ 110 cm et bra size \<D
• absence of reconstructive breast surgery
• patient able to undergo blood samples (haematological conditions allowing blood sample)
• non-evolving carcinological disease
• absence of systemic inflammatory disease (other than scleroderma) or diabetes
• invasive or in situ breast carcinoma
• ability to provide an informed written consent form
• affiliation to a social security system
• Then stratification into two groups :
• group 1 : radio-sensitive patients
• Post-operative radiotherapy completed at least 6 months ago AND

You may not qualify if:

• age \<18 or \> 70 years old
• evolutive cancer / metastatic disease
• chest size \> 110 cm et bra size ≥ D
• previous reconstructive breast surgery
• ECOG performance status \> 1
• systemic inflammatory disease or diabetes
• anemic patients
• use of oral anticoagulants
• pregnant or likely to be in 6 months
• patients deprived of liberty or under supervision
• non-affiliation to a social security system

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• VOGIN GUILLAUME, MD, PhD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• BEHM-ANSMANT Isabelle, PhD

  UMR 7365 CNRS-Université de Lorraine, IMoPA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 22, 2016
• Study Start: May 10, 2017
• Primary Completion: April 18, 2018
• Study Completion: April 25, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)