Clinical trial NCT02310711: Multi-scale Modeling of Breast Conserving Therapy
Official title: A Pilot Study for the Identification of Targets for Clinical Improvement in Breast Conserving Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast
Mastectomy
Lumpectomy
Breast Therapy
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer who are having BCT and who satisfy the following criteria will be considered for participation in this study.

Brief summary: The proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving BCT. The study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving their BCT surgery and will be followed for six months after the BCT surgery. A total of 6 visits (not including the surgery) are planned.

Detailed description: This is a single-center, prospective, pilot observation study. Eligible subjects who enroll in this study will begin at the time of informed consent, which will occur during the pre-operative, surgical evaluation time. Once consented, a 3-dimensional 180° camera surface image will be taken and a pain-scale score will be completed. Data from the medical history will be recorded. As standard of care, the surgery will be scheduled and performed. Following surgery, a series of 5 standard of care visits will occur over the subsequent 6 months, that will include research measures of local ultrasound x5 and 3-dimensional surface imaging x3. The pain scale score will be administered pre and post ultrasound on the 5 post-operative visits. A judging of the cosmesis will take place at weeks 10 and 26 by independent surgeons. The participant's role in the study will be completed after the week 24 visit.

Eligibility criteria: Inclusion Criteria:

1. Adult females ≥ age 30 years
2. Have early stage (Stage I, II), non-metastatic breast cancer
3. Planned to receive BCT
4. Have received a pre-operative mammogram within 30 days of surgery
5. Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery
6. Planned to receive post-surgery radiotherapy by whole breast radiotherapy
7. Signed informed consent form prior to any research assessment

Exclusion Criteria:

1. Adult females younger than 30 years of age
2. Previous breast cancer
3. Neo-adjuvant therapy for breast cancer
4. Pregnant or nursing females
5. Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug

Primary outcomes:
measure: Study Endpoint
timeFrame: Six-month Post-Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hopsital
state: Texas
Study officials:
affiliation: Chair, Department of Sugery
name: Barbara Bass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmon R, Garbey M, Moore LW, Bass BL. Interrogating a multifactorial model of breast conserving therapy with clinical data. PLoS One. 2015 Apr 23;10(4):e0125006. doi: 10.1371/journal.pone.0125006. eCollection 2015.