Skip to main content
OpenTrials
Completed

NCT Number: NCT03762642

Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients

Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Core management of breast cancer includes surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy (removal of the whole breast). Choosing between these two procedures may be influenced by factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the prevalence of BCS and mastectomy and the factors that may influence the choice of procedure. This retrospective study was carried out by reviewing the records of female breast cancer patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009 to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence. Using frequencies for the rate, and multivariate tests, the investigators analyzed different demographic, clinicopathological, and radiological factors to detect correlations with procedure choice.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine

Jeddah, Mecca Region, 00966, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female, diagnosed with breast cancer, underwent surgery on the breast tumor in King Abdulaziz University Hospital

Exclusion criteria

  • Patients with metastatic breast cancer or recurrence of the cancer before the surgery

Treatment and study plan

mastectomy

Procedure

Removal of the whole breast

Breast-conserving surgery

Procedure

Removal of the cancerous tissue only

Other names: Lumpectomy

Primary outcomes

  1. Prevalence of each of mastectomy and breast-conserving surgery

    Time frame: 2009-2017

    The percentage of of patients who underwent each surgery

Secondary outcomes

  1. The relationship between the choice of procedure and the patients' age (in years)

    Time frame: 2009-2017

    Statistical analysis using independent sample T-test and binary logistic regression

  2. The relationship between the choice of procedure and the use of preoperative chemotherapy (also called "neoadjuvant chemotherapy")

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

  3. The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

  4. The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

  5. The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

  6. The relationship between the choice of procedure and the tumor's size (in centimeters)

    Time frame: 2009-2017

    Statistical analysis using independent sample T-test and binary logistic regression

  7. The relationship between the choice of procedure and the tumor's stage (using the 7th "American Joint Committee on Cancer"'s staging guidelines)

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

  8. The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

  9. The relationship between the choice of procedure and the tumor's receptor status (whether it is positive for estrogen, progesterone, and/or human epidermal growth factor receptor 2)

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

  10. The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings

    Time frame: 2009-2017

    Statistical analysis using Chi-square test and binary logistic regression

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Trends of Mastectomy and Breast-Conserving Surgery and Related Factors in Female Breast Cancer Patients Treated at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2009-2017

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2018
Registry last updated
Dec 6, 2018

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.

Published trials that share one or more normalized conditions with this study.