Breast CancerNCT05654571
Weight Loss and Breast Cancer
An observational study of Breast Cancer and Obesity, Morbid, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, Obesity, Morbid
- What is being tested?
- mammography
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 1 May 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female patients over 40 years of age
Who may be able to join
- 40 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, 34734
anıl ergin, +902165783000, dranilergin@gmail.com
About this study
Official title: Evaluation of the Relationship Between Weight Loss and Breast Cancer After Laparoscopic Sleeve Gastrectomy Surgery
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.
Read the detailed description
In this study, 300 female patients who underwent laparoscopic sleeve gastrectomy due to morbid obesity in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included. The number of samples was calculated by performing impact power analysis.
Mamagrophy is recommended for all women over the age of 40 as part of the routine cancer screening program in our country. For this reason, it is assumed that female patients over the age of 40 who have undergone LSG operation have undergone mammography as of 2022. For this reason, the data of these patients will be examined by scanning from the hospital system. Patients who have undergone mammography examination at least 3 years after the LSG operation will be included in the study. The mammograms of the patients who underwent mammography in January 2015 and later will be evaluated. The final diagnosis of breast cancer will be made with the pathology result in patients with suspicious appearance on mamagrophy.
If there is a malignancy detected as a result of the examinations, its size and pathology will be recorded. Patients' age, gender, and total weight loss will be recorded.
In this retrospective study, we aimed to determine the incidence of breast cancer in patients who had undergone LSG surgery and also to determine whether there was a change in breast cancer compared to weight loss.
The patient inclusion criteria are as follows:
- 40 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
The patient exclusion criteria are as follows:
- 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
- Conditions
- Breast Cancer, Obesity, Morbid
- Being tested
- mammography
- Keywords
- breast cancer, obesity, laparoscopic sleeve gastrectomy, wight loss, mammography
- Medical subject headings
- Breast Neoplasms, Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mammographyDiagnostic test
All patients are checked for mammography every year after surgery.
| Study group | Role | What they receive |
|---|---|---|
| significant weight loss+ breast cancer | The group that lost significant weight after laparoscopic sleeve gastrectomy and was diagnosed with breast cancer Receives: 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 Receives: Diagnostic Test: mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 year
Secondary outcomes (1)
breast cancer incidance
Comparison of breast cancer incidence in those who lose weight after laparoscopic sleeve gastrectomy with the normal population
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654571
- Sponsor's protocol ID
- ANILERGİNN
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If there is a request for the sharing of data, it will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Weight Loss and Breast Cancer After Laparoscopic Sleeve Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT05654571
- Acronym / sponsor ID
- ANILERGİNN
- Conditions
- Breast Cancer, Obesity, Morbid
- Keywords
- breast cancer, obesity, laparoscopic sleeve gastrectomy, wight loss, mammography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, 300 female patients who underwent laparoscopic sleeve gastrectomy due to morbid obesity in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included. The number of samples was calculated by performing impact power analysis.
Mamagrophy is recommended for all women over the age of 40 as part of the routine cancer screening program in our country. For this reason, it is assumed that female patients over the age of 40 who have undergone LSG operation have undergone mammography as of 2022. For this reason, the data of these patients will be examined by scanning from the hospital system. Patients who have undergone mammography examination at least 3 years after the LSG operation will be included in the study. The mammograms of the patients who underwent mammography in January 2015 and later will be evaluated. The final diagnosis of breast cancer will be made with the pathology result in patients with suspicious appearance on mamagrophy.
If there is a malignancy detected as a result of the examinations, its size and pathology will be recorded. Patients' age, gender, and total weight loss will be recorded.
In this retrospective study, we aimed to determine the incidence of breast cancer in patients who had undergone LSG surgery and also to determine whether there was a change in breast cancer compared to weight loss.
The patient inclusion criteria are as follows:
- 40 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
The patient exclusion criteria are as follows:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| significant weight loss+ breast cancer | – | Diagnostic Test: mammographyThe group that lost significant weight after laparoscopic sleeve gastrectomy and was diagnosed with breast cancer |
| regain+breast cancer | – | Diagnostic Test: mammographyThe 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients over 40 years of age
Key inclusion criteria (3 listed)
- 40 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mammographyAll patients are checked for mammography every year after surgery. | Diagnostic test | regain+breast cancer, significant weight loss+ breast cancer |
Primary outcome
breast cancer incidence after laparoscopic sleeve gastrectomy
Time frame: 5 year
Comparison of breast cancer incidence in those who lost weight after laparoscopic sleeve gastrectomy and those who did not.
1 secondary outcome
breast cancer incidance
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: Undecided. If there is a request for the sharing of data, it will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Obesity, Morbid, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANIL ERGİN (+905342245364, dranilergin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast cancer incidence after laparoscopic sleeve gastrectomy (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.