NCT04541537

Brief Summary

To ascertain the possibilities to isolate the breast cancer olfactive signature

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 1, 2020

Last Update Submit

September 17, 2025

Conditions

Breast CancerSurgery

Outcome Measures

Primary Outcomes (1)

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

    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.

    18 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®)

    18 months

  • Ascertain breast cancer detection by the dogs of Curie Institut

    18 months

Study Arms (2)

Sorbstar®

EXPERIMENTAL

Odour sampling : rub hands with Sorbstars® 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: Dog Detection

Interventions

Sorbstar®DIAGNOSTIC_TEST

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

Sorbstar®
Dog DetectionDIAGNOSTIC_TEST

Analysed by the dogs of Curie Institute at the training centers

Dog Detection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (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)
  • ECOG 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
  • Pregnant or lactating women
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

Related Publications (1)

  • Leemans M, Cuzuel V, Bauer P, Baba Aissa H, Cournelle G, Baelde A, Thuleau A, Cognon G, Pouget N, Guillot E, Fromantin I, Audureau E. Screening of Breast Cancer from Sweat Samples Analyzed by 2-Dimensional Gas Chromatography-Mass Spectrometry: A Preliminary Study. Cancers (Basel). 2023 May 26;15(11):2939. doi: 10.3390/cancers15112939.

    PMID: 37296901RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fromantin Isabelle, PhD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: Experimental, interventional, prospective, open, monocentric study with risks and minimal constraints
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 9, 2020

Study Start

January 25, 2021

Primary Completion

December 9, 2021

Study Completion

December 20, 2021

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

FR(1)