Assessing breast cancer risk using ultrasound in women with dense breasts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international multicenter study aims to validate the association between sonographic glandular tissue component (GTC) and the risk of developing breast cancer in women with dense breasts. It will enroll 16,164 women aged 40 to 70 who have dense breast tissue as classified by mammography. The study will assess the amount of glandular tissue relative to fibrous stroma using breast ultrasound and will track participants for breast cancer diagnosis over time. The goal is to determine if GTC can provide additional risk assessment information beyond existing factors.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. be ≥ 40 and \<70 years old at time of US
2. No history of previous breast cancer including DCIS
3. have dense breasts (BI-RADS category C and D on mammography performed within 12 months of breast US) and negative/benign BI-RADS assessment categories on mammography (BI-RADS 1, 2)
4. undergoing screening breast US using either automated or handheld device

Exclusion Criteria

1. history of bilateral prophylactic mastectomy
2. history of bilateral foreign body injection
3. history of bilateral breast implants
4. history of bilateral breast reduction surgery or surgical excision
5. currently pregnant or breast feeding in the preceding 6 months
6. Known distant metastasis from other primary cancer

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Woo Kyung Moon, MD, PhD — Seoul National University Hospital
• Study coordinator: Woo Kyung Moon, MD, PhD
• Email: moonwk1963@gmail.com
• Phone: +82220722584

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.