RNA and Heat Shock Protein Biomarkers in Radiation-induce... | NCT03000764

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

NCT03000764

Sponsor

Institut de Cancérologie de Lorraine

Status

Completed

Last Update Posted

Aug 8, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Breast Carcinoma
Fibrosis

Interventions

skin biopsies
blood samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2017Actual

Primary Completion Date

Apr 18, 2018Actual

Completion Date

Apr 25, 2018Actual

First Submitted Date

Dec 19, 2016

First Submission Date that Met QC Criteria

Dec 19, 2016

First Posted Date

Dec 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
Biomarkers	Experimental		Other: skin biopsies Other: blood samples

Name	Type	Description	Arm Group Labels	Other Names
skin biopsies	Other	Biopsies (12 G) will be performed : in non-irradiated breast skin in irradiated breast skin	Biomarkers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
VOGIN GUILLAUME, MD, PhD	Institut de Cancérologie de Lorraine	Principal Investigator
BEHM-ANSMANT Isabelle, PhD	UMR 7365 CNRS-Université de Lorraine, IMoPA	Principal Investigator

ID	Term
D001943	Breast Neoplasms
D005355	Fibrosis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis