Breast CarcinomaSPLICI-RadNCT03000764
RNA and Heat Shock Protein Biomarkers in Radiation-induced Fibrosis in Breast Cancer
A study testing skin biopsies and blood samples in people with Breast Carcinoma and Fibrosis, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Carcinoma, Fibrosis
- What is being tested?
- skin biopsies and blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2017to 25 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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) .
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Study of RNA and Heat Shock Protein (HSP) Derived Biomarkers in Radiation-induced Fibrosis in Patients Treated for Breast Cancer.
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
- Being tested
- skin biopsies, blood samples
- Keywords
- Skin biopsy, Radiotherapy, RNA biomarker, HSP biomarker, Exon junction array, Gene expression, Radiosensitivity prediction
- Medical subject headings
- Breast Neoplasms, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsiesOther
Biopsies (12 G) will be performed :
- in non-irradiated breast skin
- in irradiated breast skin
blood samplesOther
blood samples are collected:
- 10 ml in EDTA tube
- 2,5 ml in PAXgene Blood RNA tube
- 4 ml in EDTA tube
| Study group | Role | What they receive |
|---|---|---|
| Biomarkers | Experimental | Not described Receives: Other: skin biopsies; Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (8)
Transcriptomic signature of pathological induced fibrosis when comparing the primary outcome between the two populations on cultured fibroblasts
Measured: 6 months
Transcriptomic signature of pathological induced fibrosis when comparing the primary outcome between the two populations on serum
Measured: 6 months
Individual radiosensitivity on healthy dermal fibroblasts
The micronuclei will be counted 24 hours after ex vivo irradiation with an indirect immunofluorescence assay (53BP1 + pATM antibodies)
Measured: 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
Measured: 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
The cellular distribution is defined as the compartment (nucleoplasm, nucleolus, intra-nuclear corpuscles, cytosol, RE, mitochondria ...) marked by the fluorescent probe labeled to the non-coding RNAs of interest (RNA-FISH)
Measured: 6 months
seric HSP proteins potentially predictive of pathological induced fibrosis
HSP27, HSP70 and αB crystalline measured in serum with ELISA assay
Measured: 6 months
Cellular distribution of specific HSP on fibroblast culture in each group of patients
immunolabeling of HSPs and spatial mapping and sub-nuclear distributions
Measured: 6 months
Potential interactions between DNA damage response proteins and candidate HSP
Collocation of HSPs with pATM and 53-BP1 (confocal microscopy / FLIM)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start10 May 2017
- Primary completion18 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VOGIN GUILLAUME, MD, PhD, Principal investigator, Institut de Cancérologie de LorraineBEHM-ANSMANT Isabelle, PhD, Principal investigator, UMR 7365 CNRS-Université de Lorraine, IMoPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000764
- Sponsor's protocol ID
- 2016-A00592-49
- Acronym
- SPLICI-Rad
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of RNA and Heat Shock Protein (HSP) Derived Biomarkers in Radiation-induced Fibrosis in Patients Treated for Breast Cancer.
- ClinicalTrials.gov ID
- NCT03000764
- Acronym / sponsor ID
- SPLICI-Rad / 2016-A00592-49
- Conditions
- Breast Carcinoma, Fibrosis
- Keywords
- Skin biopsy, Radiotherapy, RNA biomarker, HSP biomarker, Exon junction array, Gene expression, Radiosensitivity prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarkers | Experimental | Other: skin biopsies, Other: blood samples |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- women
- age ≥ 18 and <70 years old
- non metastatic disease
- ECOG performance status 0 or 1
- chest size ≤ 110 cm et bra size <D
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsiesBiopsies (12 G) will be performed : * in non-irradiated breast skin * in irradiated breast skin | Other | Biomarkers |
| blood samplesblood samples are collected: * 10 ml in EDTA tube * 2,5 ml in PAXgene Blood RNA tube * 4 ml in EDTA tube | Other | Biomarkers |
Primary outcome
Global mRNA alternative splicing and expression of non-coding RNAs profiles in healthy dermal fibroblasts
Time frame: 6 months
frequency of inclusion of individual exons within the set of mRNA isoforms (overall splicing profile) and variation in expression of non-coding RNAs
8 secondary outcomes
Transcriptomic signature of pathological induced fibrosis when comparing the primary outcome between the two populations on cultured fibroblasts
Time frame: 6 months
Transcriptomic signature of pathological induced fibrosis when comparing the primary outcome between the two populations on serum
Time frame: 6 months
Individual radiosensitivity on healthy dermal fibroblasts
Time frame: 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
Time frame: 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
Time frame: 6 months
seric HSP proteins potentially predictive of pathological induced fibrosis
Time frame: 6 months
Cellular distribution of specific HSP on fibroblast culture in each group of patients
Time frame: 6 months
Potential interactions between DNA damage response proteins and candidate HSP
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VOGIN GUILLAUME, MD, PhD principal investigator
Institut de Cancérologie de Lorraine
BEHM-ANSMANT Isabelle, PhD principal investigator
UMR 7365 CNRS-Université de Lorraine, IMoPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsies and blood samples in people with Breast Carcinoma and Fibrosis, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global mRNA alternative splicing and expression of non-coding RNAs profiles in healthy dermal fibroblasts (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.