Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00756834
Eligibility Criteria:
Inclusion Criteria:
1. Mammograms obtained from women 40 years of age and over;
2. Mammograms obtained from women only;
3. There are at least four standard views (right cranio-caudal \[RCC\], right medio-lateral oblique \[RMLO\], left cranio-caudal \[LCC\], left medio-lateral oblique \[LMLO\]) of the breast;
4. Informed consent is obtained.
Mammograms of biopsy-proven cancer cases will be considered eligible for inclusion in the study if they meet the following criteria:
5. Biopsy-proven malignant case that was assigned a BI-RADS category 4 or 5 with a suspicious lesion and the corresponding pathology report for the suspicious lesion is available.
6. Cases which have one or more lesion.
Routine screening "Normal" cases will be considered eligible for inclusion in the study if they meet the following criteria:
7. The case is a routine screening mammogram assigned a BI-RADS category 1 or 2 by a certified radiologist
Exclusion Criteria:
Cases are excluded from the study if they have any of the following conditions:
1. Mammographic needle projection or pre-biopsy markings are evident on the mammogram (these may cause false marks).
2. The mammograms include artifacts created by breast implant.
3. The mammograms are of poor quality (e.g., the digital image has very poor contrast);
Mammograms of biopsy-proven cancer cases will be excluded from the study if they have any of the following conditions:
4. Cases in which the lesion is only palpable or visible by another modality (e.g., Ultrasound, MRI).
5. The pathology is not related to a specific region. That is, there is more than one biopsy region and the pathology reports cannot be related to the appropriate mammographic lesion. For example, a mammogram with multiple lesions and multiple related pathology reports on the same date and it is not clear which pathology report belongs to each lesion.
6. The pathology report is more than three months after the FFDM or FSM mammogram.
7. The mammogram was performed for the purpose of planning cancer therapy (e.g., radiation) (BIRADS 6).
8. Cases in which the lesion is characterized as an architectural distortion. -
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT00756834
Study Brief:
Protocol Section:
NCT00756834