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:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT03991468
Eligibility Criteria:
Inclusion Criteria:
* Cases originating from and that were diagnosed at that local site
* Cases are available in the site's archive
* Cases are at least 1 year old since accessioning
* Cases are selected because their primary diagnosis is consistent with the assigned target categories
* Cases have a set of slides representative of the primary diagnosis for which it has been selected
Slide selection for a given case must meet the following criteria:
* Slide is obtained by surgical pathology and prepared from FFPE human tissue
* Slides must be stained with H\&E and accompanying special stains (histochemical and/or immunohistochemical)
* All special stains slides (histochemical and/or immunohistochemical) where the slide and stain is used for diagnosis, not prognosis.
* A chosen slide must demonstrate and be representative of the primary diagnosis; 1 slide selection may suffice for biopsy cases,
* For resection cases, a minimum of 5 slides must be selected, which represent the primary diagnosis. If represented with less than 5 slides, additional slides (primary, secondary, or benign slides) from same case may be used to fulfill minimum number
* Slide is intact, has correct size/thickness, good edges, undamaged coverslip, without pen markings that can't be removed, no air bubbles, tidy labels, and fulfills the quality checks per the general clinical practice
Exclusion Criteria:
* Case does not have relevant slides or if case information necessary for the study is missing
* Case is still active (less than 1 year old) at the local site
* Cases for which the control slides for immunohistochemistry and special stains are not available
* Two cases from same individual
* Gross-only cases that have no slides
* Cases that are frozen section, cytology or hematology or immunofluorescence specimens only
* Case where the only available set of slides have evidence only of secondary or no diagnoses and not the primary diagnosis for which the case is being screened.
Slides for a given case will be excluded if they meet the following criterion:
• Glass slide that is broken, has abnormal size/thickness, beveled edges, poor coverslip (cracks, waviness, scratches), is sticky, has many pen markings or dirt that cannot be removed, contains air bubbles and overhanging labels that can't be corrected, and if stain is severely faded.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03991468
Study Brief:
Protocol Section:
NCT03991468