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Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

NCT ID: NCT03703557

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2020-09-20

Brief Summary

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To ascertain the possibilities to isolate the breast cancer olfactive signature.

Detailed Description

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Patient recruitment during the first surgery consultation in Curie Institute. Odor sampling (non-invasive) with an odor-sensing polymer (Sorbstar® polymer developed especially for the trace level analysis), on:

* The hands, before and after surgical excision of the tumor (friction of the hands)
* The diseased breast, before and after surgical excision of the tumor (via a compress positioned on the breast for 1 night)
* The tumor, during the surgical procedure (odor collection over a tumor sample).

Each patient will be her own witness, before and after surgical excision, in an attempt to isolate the chemical signature tracks of breast cancer. The samples after surgery will be made after healing and before implementation of a treatment (chemotherapy and / or radiotherapy).

Conditions

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Breast Cancer Surgery

Keywords

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Breast Volatile organic compounds

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Interventional, prospective, open, monocentric study with risks and minimal constraints
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sorbstar®

Odour sampling: Rub hands with Sorbstar® before and post-surgery

Group Type EXPERIMENTAL

Sorbstar®

Intervention Type DIAGNOSTIC_TEST

Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.

Dog detection

Odour sampling: Sleep over a night with a compress on the affected breast before and after surgery

Group Type EXPERIMENTAL

Odour sampling

Intervention Type DIAGNOSTIC_TEST

Analyzed by the dogs of Curie Institute at the training centers

Interventions

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Sorbstar®

Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.

Intervention Type DIAGNOSTIC_TEST

Odour sampling

Analyzed by the dogs of Curie Institute at the training centers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
2. Of-Age female patient (over 18 years old)
3. Life expectancy \> to 1 year at the inclusion
4. Performance status: 0 or 1 or 2
5. Patient benefiting from the social security
6. Signature informed consent of the study

Exclusion Criteria

1. Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
2. Wound presence on breasts
3. Male subjects
4. Specified metastatic breast cancer
5. Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
6. Persons under guardianship or deprived of liberty
7. Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roman ROUZIER, Phd

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Isabelle FROMANTIN, Phd, IDE

Role: STUDY_DIRECTOR

Institut Curie

Locations

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INSTITUT CURIE - Site de Saint Cloud

Saint-Cloud, , France

Site Status

Countries

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France

Other Identifiers

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IC 2018-01

Identifier Type: -

Identifier Source: org_study_id