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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06151379
Other study ID # AcibademAH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date October 20, 2023

Study information

Verified date November 2023
Source Acibadem Atunizade Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.


Description:

In patients with operable breast cancer (BC) receiving neoadjuvant chemotherapy (NAC), the pathological response rate was found to be related to body composition. The success of complete pathologic response (pCR) is a known prognostic factor in BC patients treated with NAC. The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date October 20, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers
Gender Female
Age group 29 Years to 72 Years
Eligibility Inclusion Criteria: - Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy. Exclusion Criteria: - Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neoadjuvant therapy
To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Locations

Country Name City State
Turkey AcibademAH Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Acibadem Atunizade Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Residual cancer burden Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. Through study completion, an average of 1 year.
Primary Sarcopenic index skeletal muscle area (cm2)/height (m2) et L3 level Through study completion, an average of 1 year.
Secondary Body mass index weight (kg)/height (m2) Through study completion, an average of 1 year.
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