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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04457167
Other study ID # RMR-IPC 2017-039
Secondary ID 2020-A01644-35
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date November 1, 2026

Study information

Verified date June 2020
Source Institut Paoli-Calmettes
Contact Dominique Genre
Phone 33491223778
Email DRCI.UP@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.


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-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 480
Est. completion date November 1, 2026
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age = 18 years old,

2. Signed consent to participate,

3. Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations, PALB2, extensive border lesions)

4. Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case

5. Mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis,

6. immediate breast reconstruction by autologous latissimus dorsi flap

7. immediate breast reconstruction by latissimus dorsi flap and prosthesis,

8. secondary breast reconstruction by latissimus dorsi flap

9. Affiliation to, or beneficiary of, a social security scheme.

Exclusion Criteria:

1. Patient under 18,

2. Pregnant woman or likely to be (without effective contraception) or breastfeeding,

3. 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,

4. Inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Robot-assisted
robot-assisted surgery
Procedure:
Not robot-assisted surgery
Not robot-assisted surgery

Locations

Country Name City State
France Institut Paoli-Calmettes Marseille

Sponsors (1)

Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of postoperative early complications To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days) 90 days
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