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

NCT03762642 | Completed

• 1 other identifier: 357-71
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Breast Neoplasms; Breast Cancer Female

Keywords

Breast Cancer Surgery; Lumpectomy; Surgery Choice; Procedure Choice; Surgical Outcome

Outcome Measures

Primary Outcomes (1)

• Prevalence of each of mastectomy and breast-conserving surgery

  The percentage of of patients who underwent each surgery

  2009-2017

Secondary Outcomes (10)

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

  2009-2017

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

  2009-2017

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

  2009-2017

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

  2009-2017

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

  2009-2017

Study Arms (2)

Mastectomy

Procedure: Mastectomy

Breast-Conserving Surgery

Procedure: Breast-Conserving Surgery

Interventions

Mastectomy PROCEDURE

Removal of the whole breast

Mastectomy

Breast-Conserving Surgery PROCEDURE

Removal of the cancerous tissue only

Also known as: Lumpectomy

Breast-Conserving Surgery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female breast cancer patients who underwent surgery for breast cancer in King Abdulaziz University hospital between 2009 and June 2017 excluding those who had metastasis or recurrence before the surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

Faculty of Medicine

Jeddah, Mecca Region, 00966, Saudi Arabia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 4, 2018
• Study Start: July 17, 2017
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

SA (1)