RNA and Heat Shock Protein Biomarkers in Radiation-induced Fibrosis in Breast Cancer (SPLICI-Rad)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Fibrosis; Breast Carcinoma

Treatments: Other: blood samples; Other: skin biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT03000764

2016-A00592-49

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• no inflammatory ou infectious flare on biopsy site at the time of inclusion
• 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
• radiation induced dermal and/or soft tissue toxicity (dermatitis, fibrosis, atrophy) rated > 2 (CTCAE v4.0 scale)

group 2 : radio-tolerant (control) patients

• Post-operative radiotherapy completed more than 4 years ago AND
• radiation induced dermal and/or soft tissue toxicity (dermatitis, fibrosis, atrophy) rated ≤1 (CTCAE v4.0 scale) .

Exclusion criteria

• 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
• inflammatory ou infectious flare on biopsy site at the time of inclusion, very significant ulceration in the treated breast
• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Biomarkers

Experimental group

Treatment:

Other: blood samples

Other: skin biopsies