RNA and Heat Shock Protein Biomarkers in Radiation-induced Fibrosis in Breast Cancer (NCT03000764) | Clinical Trial Compass
CompletedNot Applicable
RNA and Heat Shock Protein Biomarkers in Radiation-induced Fibrosis in Breast Cancer
France20 participantsStarted 2017-05-10
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Global mRNA alternative splicing and expression of non-coding RNAs profiles in healthy dermal fibroblasts