Patient information combined for local therapy outcome assessment in breast cancer-longitudinal

Patient information combined for local therapy outcome assessment in breast cancer-longitudinal - PICTURE BREAST - L

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40672

Enrollment

Registered

2014-10-31

Start date

2014-06-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer carcinoma of the breast

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women who have undergone breast conserving surgery for early breast cancer more than one year ago. Written informed consent obtained.

Exclusion criteria

Exclusion criteria: Unable to provide written informed consent. Younger than 18 years. Benign breast disease. Women who have had a mastectomy.

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to create a reliable demonstrator (software) by integrating models of surgical techniques and treatment schemes, clinical patient data, multi-modal imaging and individualised models of patient anatomy. The demonstrator will be used as an aid to objective surgical planning, via simulation of the cosmetic effects of breast conserving surgery, as a decision support tool to communicate the available options to the patient and to enable standardised evaluation of the procedure	—

Measure

Time frame

The primary objective of the study is to create a reliable demonstrator (software) by integrating models of surgical techniques and treatment schemes, clinical patient data, multi-modal imaging and individualised models of patient anatomy. The demonstrator will be used as an aid to objective surgical planning, via simulation of the cosmetic effects of breast conserving surgery, as a decision support tool to communicate the available options to the patient and to enable standardised evaluation of the procedure

—

Secondary

Measure	Time frame
The secondary objective is to assess the health-related quality of life at baseline (before surgery) and one year after surgery, in the women who are participating in this study. Together with characteristics of the patient and the breast tumour, these data will describe the patient group on whom the demonstrator is constructed, which will be used to inform the design and size of a subsequent evaluation study.	—

Measure

Time frame

The secondary objective is to assess the health-related quality of life at baseline (before surgery) and one year after surgery, in the women who are participating in this study. Together with characteristics of the patient and the breast tumour, these data will describe the patient group on whom the demonstrator is constructed, which will be used to inform the design and size of a subsequent evaluation study.

—

Countries

Netherlands

Outcome results