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This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Conservation Cohort | Breast Conservation group (Group A) with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment. | ||
| Mastectomy and Reconstruction Cohort | Mastectomy and Reconstruction group (Group B): This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction. | ||
| Mastectomy Only Cohort | Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Measured by the Breast Q | The Breast Q is a comprehensive and specific quality of life instrument that allows for patient self-assessment prior to and following breast surgery. Comprised of quality of life and satisfaction domains, and generates domain-specific Q-scores (0-100) constructed using Rasch analysis. The higher the score, the more satisfied the participant was. -Collected preoperatively (no more than 3 months prior to surgery) and postoperatively (approximately 6 months after conclusion of radiotherapy in the Breast Conservation Cohort and >=3 months after the final balancing reconstructive intervention in the Mastectomy and Reconstruction Cohort. | Compare preoperative values with postoperative values (up to 4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Females ages 18 - 72 years of age scheduled to undergo breast conservation therapy (BCT), mastectomy or mastectomy with immediate reconstruction for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB).
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| Name | Affiliation | Role |
|---|---|---|
| Terence M. Myckatyn, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32350679 | Derived | Dolen U, Thornton M, Tenenbaum MM, Aripoli A, Patel A, Cyr AE, Yan Y, Appleton CM, Margenthaler JA, Myckatyn TM. A prospective cohort study to analyze the interaction of tumor-to-breast volume in breast conservation therapy versus mastectomy with reconstruction. Breast Cancer Res Treat. 2020 Jun;181(3):611-621. doi: 10.1007/s10549-020-05639-w. Epub 2020 Apr 30. |
| Label | URL |
|---|---|
| This website allows for direct access to the West County Plastic Surgeons' web site. | View source |
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Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Conservation Cohort | Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment. |
| FG001 | Mastectomy and Reconstruction Cohort | Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction. |
| FG002 | Mastectomy Only Cohort | Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Conservation Cohort | Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment. |
| BG001 | Mastectomy and Reconstruction Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life as Measured by the Breast Q | The Breast Q is a comprehensive and specific quality of life instrument that allows for patient self-assessment prior to and following breast surgery. Comprised of quality of life and satisfaction domains, and generates domain-specific Q-scores (0-100) constructed using Rasch analysis. The higher the score, the more satisfied the participant was. -Collected preoperatively (no more than 3 months prior to surgery) and postoperatively (approximately 6 months after conclusion of radiotherapy in the Breast Conservation Cohort and >=3 months after the final balancing reconstructive intervention in the Mastectomy and Reconstruction Cohort. | -Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction | Posted | Mean | Standard Deviation | score on a scale | Compare preoperative values with postoperative values (up to 4 years) |
|
This is an observational study as such adverse events were not collected.
This is an observational study as such adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Conservation Cohort | Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terence M. Myckatyn, M.D. | Washington University School of Medicine | 314-996-3873 | myckatyn@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2018 | Mar 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.
| BG002 | Mastectomy Only Cohort | Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Breast Conservation Cohort | Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment. |
| OG001 | Mastectomy and Reconstruction Cohort | Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction. |
| OG002 | Mastectomy Only Cohort | Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Mastectomy and Reconstruction Cohort | Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Mastectomy Only Cohort | Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |