PATHO dataset

Local lab pathology results. It should contain entry biopsy, for-cause biopsy, and surgery dates.

BIOPSY dataset

should contain the 24 month scheduled biopsies (Visit 6) and the 48 month scheduled biopsies (Visit 10).

PATHOLOG dataset

Central lab pathology results.It is important to note that the Central Lab pathology results for all data in PATHO and BIOPSY should be in the PATHOLOG dataset. These Central Lab pathology results are of primary interest (as opposed to the local pathology lab results provided in the PATHO dataset). Hence you should in theory be able to match up every biopsy or surgery date that is in PATHO and BIOPSY with the corresponding Central Lab pathology results in PATHOLOG by subject number, procedure type and procedure date.

1. Cleason data
2. HGPIN
3. % core involved and # of cores with cancer
4. Treatment alteration scores

postbaseBiop dataset

This dataset includes the biopsy results (unscheduled, scheduled, surgery) for each subject. Subjects may have multiple records, but each record will have a unique biopsy date (PRCDT). To be continued...

The For-Cause Biopsy spreadsheet

It is provided by the Central Lab (Bostwick Labs) on an irregular basis and is essentially a log-in record. That is, it is an operational record of when biopsy material is checked into the Central Lab, along with various other data attached as well. It does not replace PATHOLOG and is only to be used as supplemental information to indicate how many biopsies have been received

Notations

"ASAP" indicates presence of atypical small acinar proliferation, "CAG" means cancer diagnosed.

Biopsy Reporting

Final Reporting

Final reporting of the biopsy data should be based on the PATHOLOG dataset alone (since it is Central Lab pathology results - the protocol section 6.3.2).

Interim reporting

PATHOLOG should be the primary source of the data (since it is Central Lab pathology results), and it has to be supplemented by PATHO, BIOPSY and FOR-CAUSE-BIOPSY. The for-cause biopsy spreadsheet can be utilized if there is no corresponding PATHOLOG data, understanding that the data so used should be considered tentative. If any data inconsistencies arise: PATHOLOG is prefered to PATHO, BIOPSY and FOR-CAUSE-BIOPSY, FOR-CAUSE-BIOPSY is prefered to PATHO.