Body Composition and White Adipose Tissue Inflammation
1 other identifier
observational
202
1 country
9
Brief Summary
The investigators want to find a better way to predict the risk of having fatty tissue inflammation by using a different approach to finding out body fat composition. In this study, the investigators want to estimate the body fat composition using a DEXA scan. DEXA stands for dual energy X-ray absorptiometry. It is the standard and established test to determine bone mineral density (how strong the bones are) to diagnose osteoporosis. This test can also be used to determine the body composition including percent body fat and lean mass. The investigators will compare the participants DEXA scan results for body fat composition to the inflammation found in the breast tissue from the mastectomy to see if there is a relationship. If successful, this may help us predict which patients may be at risk for breast cancer in the future. In addition, the investigators will compare the participants DEXA scan results for body fat composition and inflammation found in the fat tissue from the mastectomy or prostatectomy to the level of exercise activity as measured by a short questionnaire to see if there is a relationship. The investigators will also measure the participants waist to hip ratio. Finally, at the time the participant has blood drawn for their standard presurgical testing, the investigators will also test the blood for prediabetes using a blood test called hemoglocin A1c. The investigators will also measure for the participants waist to hip ratio, and a Hgb A1c blood drawn will be take at the time of presurgical testing. If not feasible, Hgb A1c can be drawn at a separate visit prior to the DEXA scan. If successful, this may help us predict which patients may be at risk for breast cancer in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2015
CompletedFirst Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2023
CompletedNovember 8, 2023
November 1, 2023
8 years
March 11, 2016
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
fat percentage
as measured by DEXA
1 year
presence of White Adipose Tissue Inflammation (WATi )
as measured by DEXA
1 year
Study Arms (2)
Breast Cancer
DEXA scan will be carried out 1 to 30 days prior to mastectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.
Prostate Cancer
DEXA scan will be carried out 1 to 30 days prior to radical prostatectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.
Interventions
Eligibility Criteria
This study is open to patients undergoing prophylactic or therapeutic mastectomy or radical prostatectomy at MSKCC. Patients will be identified and recruited from the Breast Service at and Plastics and Reconstructive Surgery Clinics MSKCC and approached at the time of initial surgical consultation.
You may qualify if:
- Age ≥ 18
- Female
- All BMIs
- Patients undergoing mastectomy at MSKCC (i.e. Nipple-sparing mastectomy, skin-sparing mastectomy, simple mastectomy, modified radical mastectomy, radical mastectomy); mastectomy may be either prophylactic or therapeutic. OR
- Patients undergoing hysterectomy at MSKCC
- History of prior breast surgeries/procedures is acceptable
You may not qualify if:
- Pregnancy (confirmed or suspected);
- Inability to lay supine on equipment table and maintain the position for the necessary time;
- Weight superior to the maximum allowed by the DEXA machine (over 350 lbs or 158 kg);
- Greater than 10% baseline weight loss in the past year;
- Planned surgical procedure is not a Mastectomy (i.e. breast conservation surgery or other non-mastectomy procedure; such as lumpectomy) or hysterectomy
- Metastatic cancer
- History of Wasting Syndromes or Cachexia
- Use of daily NSAIDs, aspirin, or steroids (other than inhaled or topical) within 30 days of surgery
- Use of neoadjuvant systemic or radiation therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Waters Corporation (Data Analysis Only)
Milford, Massachusetts, 01757, United States
Memorial Sloan Kettering Cancer Center (Consent Only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604, United States
Weill Medical College of Cornell University (Data and Specimen Analysis Only)
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Iyengar, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 18, 2016
Study Start
November 4, 2015
Primary Completion
November 7, 2023
Study Completion
November 7, 2023
Last Updated
November 8, 2023
Record last verified: 2023-11