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

NCT03703557 | Completed

• 1 other identifier: IC 2018-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Surgery

Keywords

Breast; Volatile organic compounds

Outcome Measures

Primary Outcomes (1)

• Ascertain breast cancer olfactive signature (Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®)

  Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®) on hands. Friction of the hands according to the protocol before and after surgical excision of the tumor. Sorbstar® analyses will be performed with a thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.

  12 months

Secondary Outcomes (2)

• Ascertain breast cancer olfactive signature from the tumor (Isolation of volatile Organic Compounds to tumor breast samples by a sensitive technique with an odor-sensing polymer (Sorbstar®).

  13 months

• Ascertain breast cancer detection by the dogs of Curie Institut

  13 months

Study Arms (2)

Sorbstar®

EXPERIMENTAL

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

Diagnostic Test: Sorbstar®

Dog detection

EXPERIMENTAL

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

Diagnostic Test: Odour sampling

Interventions

Sorbstar® DIAGNOSTIC_TEST

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

Sorbstar®

Odour sampling DIAGNOSTIC_TEST

Analyzed by the dogs of Curie Institute at the training centers

Dog detection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
• Of-Age female patient (over 18 years old)
• Performance status: 0 or 1 or 2
• Patient benefiting from the social security
• Signature informed consent of the study

You may not qualify if:

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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

INSTITUT CURIE - Site de Saint Cloud

Saint-Cloud, 92210, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Roman ROUZIER, Phd

  Institut Curie

  PRINCIPAL INVESTIGATOR

• Isabelle FROMANTIN, Phd, IDE

  Institut Curie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, open, monocentric study with risks and minimal constraints

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: October 12, 2018
• Study Start: July 25, 2018
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

FR (1)