NCT02713022Completed
Body Composition and White Adipose Tissue Inflammation
Source: ClinicalTrials.gov · Last updated 8 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 202 (actual)
- First submitted
- 11 Mar 2016
- Start date
- Nov 2015
- Primary completion date
- Nov 2023
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT02713022
What you commit to
- Study type: Observational
- Participants enrolled: 202
- From Nov 2015 to the primary completion date, Nov 2023
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgical procedure is not a Mastectomy (i.e. breast conservation surgery or other non-mastectomy procedure; such as lumpectomy) or hysterectomy
- Use of daily NSAIDs, aspirin, or steroids (other than inhaled or topical) within 30 days of surgery
- Use of neoadjuvant systemic or radiation therapy.
Other illness
- Metastatic cancer
- History of Wasting Syndromes or Cachexia
Other
- 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;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (Consent Only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester (Consent only) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth (Consent Only) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Waters Corporation (Data Analysis Only) Coordinator of this site? Confirm its status | Milford | United States | Unknown status |
| Memorial Sloan Kettering Bergen (Consent Only) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Medical College of Cornell University (Data and Specimen Analysis Only) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau (Consent Only) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.