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Completed

NCT Number: NCT03703557

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

INSTITUT CURIE - Site de Saint Cloud

Saint-Cloud, 92210, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Life expectancy > to 1 year at the inclusion
  • Performance status: 0 or 1 or 2
  • Patient benefiting from the social security
  • Signature informed consent of the study

Exclusion criteria

  • 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.

Treatment and study plan

Sorbstar®

Diagnostic Test

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

Odour sampling

Diagnostic Test

Analyzed by the dogs of Curie Institute at the training centers

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®)

    Time frame: 12 months

    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.

Secondary outcomes

  1. 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®).

    Time frame: 13 months

    During the surgical procedure an odor-sensing polymer (Sorbstar®) over the tumor is placed. Sorbstar® analyzes will be performed with a thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.

  2. Ascertain breast cancer detection by the dogs of Curie Institut

    Time frame: 13 months

    Patients sleep over a night with a compress positioned on the affected breast before and after surgery. The compress will be analyzed by the dogs of Curie Institut (results cancer/not cancer).

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

Acronym: KDOG2

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 12, 2018
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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