- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06151379
Muscle Parameters and Pathological Response in Breast Cancer Patients
November 21, 2023 updated by: Ebru Yilmaz, Acıbadem Atunizade Hospital
The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response
The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
69
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34782
- AcıbademAH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pathologic complete response (pCR)
Patient with complete pathological response
|
To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
|
Pathologic incomplete response (non-pCR)
Patient with partial pathological response
|
To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sarcopenic index
Time Frame: Through study completion, an average of 1 year.
|
skeletal muscle area (cm2)/height (m2) et L3 level
|
Through study completion, an average of 1 year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: Through study completion, an average of 1 year.
|
weight (kg)/height (m2)
|
Through study completion, an average of 1 year.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual cancer burden
Time Frame: Through study completion, an average of 1 year.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aysun Isiklar, M.D., Acıbadem Atunizade Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
October 20, 2023
Study Registration Dates
First Submitted
November 4, 2023
First Submitted That Met QC Criteria
November 21, 2023
First Posted (Actual)
November 30, 2023
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AcıbademAH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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