Multi-scale Modeling of Breast Conserving Therapy | NCT02310711

Studies
Multi-scale Modeling of Breast Conserving Therapy

NCT02310711

Sponsor

The Methodist Hospital Research Institute

Status

Unknown status

Last Update Posted

Oct 10, 2018Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Standard of Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB0112-0007	Other Identifier	TMHRI IRB
BCTMM01	Other Identifier	Other Protocol ID

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Aug 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 4, 2014

First Posted Date

Dec 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2018

Last Update Posted Date

Oct 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Barbara Bass, Chair, Department of Surgery, The Methodist Hospital Research InstitutePrincipal Investigator

Lead Sponsor

The Methodist Hospital Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard of Care	Other	Standard of care for early stage breast cancer is breast conserving therapy at this center. Other concomitant standard of care treatment • Radiation therapy to the whole breast o 45-50 Gy delivered over 25-28 fractions with a boost to the tumor bed of 10-16 Gy delivered over 5-8 fractions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study Endpoint	The proportion of subjects with ≥60% agreement between the surgical/healing outcome of the lumpectomy and breast surface contour and the predicted changes from the multi-scale model.	Six-month Post-Surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with breast cancer who are having BCT and who satisfy the following criteria will be considered for participation in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Linda W. Moore	Contact	713-441-6144		lwmoore@houstonmethodist.org

Overall Officials

Name	Affiliation	Role
Barbara Bass, MD	Chair, Department of Sugery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Houston Methodist Hopsital	Recruiting	Houston	Texas	77030	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25906048	Background	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation