Weight Loss and Breast Cancer

NCT05654571 | Not Yet Recruiting DMC

• 1 other identifier: ANILERGİNN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is an important risk factor for postmenopausal breast cancer. A large meta-analysis concluded that obesity is associated with a 20% to 40% increased risk for receptor-positive postmenopausal breast cancer. The International Agency for Research on Cancer working group on obesity and cancer risk drew similar conclusions. Obesity seems to have the opposite effect among premenopausal women, with most studies suggesting that higher BMI is associated with a reduced risk of premenopausal breast cancer. Determining whether deliberate weight loss is associated with a reduced risk of breast cancer is difficult in part because sustained weight loss is difficult to achieve and few studies have sufficient statistical power to address this question. Bariatric surgery is one of the few weight loss interventions in which significant weight loss is maintained. A limited number of previous studies have suggested a reduced risk of cancer following bariatric surgery. Recently, it showed that bariatric surgery is associated with a lower risk of several types of cancer, including an approximately 40 % reduction in the risk of postmenopausal breast cancer. However, whether bariatric surgery affects breast cancer risk in premenopausal women and whether this association is altered by estrogen receptor (ER) status has not been addressed. The aim of this study is to examine the relationship between weight loss after laparoscopic sleeve gastrectomy (LSG) and breast cancer.

Conditions

Breast Cancer; Obesity, Morbid

Keywords

breast cancer; obesity; laparoscopic sleeve gastrectomy; wight loss; mammography

Outcome Measures

Primary Outcomes (1)

• breast cancer incidence after laparoscopic sleeve gastrectomy

  Comparison of breast cancer incidence in those who lost weight after laparoscopic sleeve gastrectomy and those who did not.

  5 year

Secondary Outcomes (1)

• breast cancer incidance

  5 year

Study Arms (2)

significant weight loss+ breast cancer

The group that lost significant weight after laparoscopic sleeve gastrectomy and was diagnosed with breast cancer

Diagnostic Test: mammography

regain+breast cancer

The group who lost significant weight after laparoscopic sleeve gastrectomy and regained it afterwards, or who could not lose weight and were diagnosed with breast cancer

Diagnostic Test: mammography

Interventions

mammography DIAGNOSTIC_TEST

All patients are checked for mammography every year after surgery.

regain+breast cancer; significant weight loss+ breast cancer

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Since the incidence of breast cancer was investigated in the study and the incidence of breast cancer in women is much higher than in men, only female patients will be included. Since all patients included in the study would undergo mammography, female patients over the age of 40 were included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

female patients over 40 years of age

You may qualify if:

• years and older (age as of 2022, not the age of operation)
• LSG was applied in our clinic due to morbid obesity.
• Patients whose mamagrofi images are available in the hospital system

You may not qualify if:

• Patients who underwent abdominal surgery again after LSG
• Patients whose mamagrophy image is not in the system
• Patients with suspicious findings as a result of mammography and who did not undergo additional imaging or biopsy
• Patients out of follow-up after the operation

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity, Morbid; Obesity

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

ANIL ERGİN

CONTACT

+905342245364; dranilergin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Uzman Doktor

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: December 15, 2022
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

TU (1)