Status:
NOT_YET_RECRUITING
Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Mastectomy
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-...
Detailed Description
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old,
- Signed consent to participate,
- Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)
- Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case
- Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,
- immediate breast reconstruction by autologous latissimus dorsi flap
- immediate breast reconstruction by latissimus dorsi flap and prosthesis,
- secondary breast reconstruction by latissimus dorsi flap
- Affiliation to, or beneficiary of, a social security scheme.
Exclusion
- Patient under 18,
- Pregnant woman or likely to be (without effective contraception) or breastfeeding,
- Person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent,
- Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04457167
Start Date
November 1 2020
End Date
November 1 2026
Last Update
July 7 2020
Active Locations (1)
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1
Institut Paoli-Calmettes
Marseille, France, 13009