Abbreviated Name

PASS: Ref Set App: MDx

Lead Investigator

Lin UW, Daniel W. — University of Washington

Coordinating Investigator

No coordinating investigator

Involved Investigators

• Lin UW, Daniel W. — University of Washington

Abstract

No abstract availalbe.

Aims

1) To determine whether the SelectMDx, collected on or shortly before the first active surveillance biopsy, can predict high-grade cancer on the first active surveillance biopsy. The performance of the SelectMDx markers will be evaluated a) on their own, b) in their ability to improve prediction using routine clinical factors, and c) compared to the known urine marker PCA3. For Study Objective 1, a minimum of 690 urine samples that occur on or shortly before the first active surveillance biopsy will be used. 2) To determine whether the SelectMDx, collected after diagnosis and before the first surveillance biopsy, can predict men who will not progress or reclassify within four years from diagnosis. The performance of the SelectMDx markers will be evaluated a) on their own, b) in their ability to improve prediction using routine clinical factors, and c) compared to the known urine marker PCA3. For Study Objective 1, a minimum of 690 urine samples that occur on or shortly before the first active surveillance biopsy will be used. 3) To determine if the SelectMDx significantly changes over time, and to assess the amount of within-participant versus between-participant variability in the SelectMDx. If changes are detected, then modeling for associations with clinical endpoints will be performed. For Study Objective 3, a minimum of 1500 serial specimens collected at 6 month intervals after the first active surveillance biopsy will be used. These serial urine specimens will be selected based on a random sample of 300 participants, with a median of 5 urine samples each. We expect to have approximately 400-500 samples from Study Objectives 1 & 2 above that will overlap with Study Objective 3.

Analytic Method

No analytic method available.

Publications

• No publications available at this time for this protocol.

Biomarkers

• No biomarkers available at this time for this protocol.

Data Collections

• No data collections available at this time for this protocol.

Start Date

Jan 1 2017

Finish Date

Oct 31 2017

Protocol ID

424

Protocol Type

Collaboration

Fields of Research

• Proteomics

Collaborative Group

Prostate and Urologic Cancers Research Group

Cancer Types

• Malignant neoplasm of prostate

Phased Status

4