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Gene Expression Classifier

Standard of care (no pre-treatment genomics testing) for Prostate Cancer

N/A

Recruiting

Led By Todd Morgan, M.D.

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years following treatment

Awards & highlights

Study Summary

This trial will help researchers understand if a certain type of genetic testing can help improve treatment for prostate cancer patients, as well as how best to use this testing in the future.

Who is the study for?

This trial is for men 18 or older with newly diagnosed favorable risk prostate cancer, having a PSA level below 20 ng/ml. Participants must have had a diagnostic biopsy within the last 9 months and have available tissue samples. It's suitable for those with Grade Group 1 cancer involving more than two biopsy cores or Grade Group 2 cancer. Men who've already had gene expression classifier testing or any prostate cancer treatment are excluded.Check my eligibility

What is being tested?

The G-MAJOR study is evaluating the impact of Gene Expression Classifier (GEC) tests like Prolaris, Decipher, and Oncotype Dx GPS on managing prostate cancer compared to standard care based on askMUSIC scores. The goal is to refine how these genomic tests are used in clinical practice and set up future research.See study design

What are the potential side effects?

Since this trial focuses on genomic testing rather than drug interventions, traditional side effects associated with medications aren't expected. However, there may be some risks related to data privacy and potential emotional impacts from learning about one's genetic risk factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is either low grade with more than 2 biopsy cores involved or is moderate grade.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years following treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years following treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years following treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic procedure

Secondary outcome measures

Mean score per arm of health-related quality of life (HRQOL)

Mean score per arm of patient reported sexual function questionnaire

Mean score per arm of patient reported urinary function questionnaire

+8 more

Trial Design

2Treatment groups

Active Control

Group I: Standard of care (no pre-treatment genomics testing)Active Control1 Intervention

Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care).

Group II: Standard of care + pre-treatment genomics testingActive Control4 Interventions

Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

MDx HealthIndustry Sponsor

4 Previous Clinical Trials

3,378 Total Patients Enrolled

2 Trials studying Prostate Cancer

1,600 Patients Enrolled for Prostate Cancer

Veracyte, Inc.Industry Sponsor

3 Previous Clinical Trials

1,000,993 Total Patients Enrolled

2 Trials studying Prostate Cancer

1,000,493 Patients Enrolled for Prostate Cancer

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,505,976 Total Patients Enrolled

28 Trials studying Prostate Cancer

6,057 Patients Enrolled for Prostate Cancer

Media Library

Decipher (Gene Expression Classifier) Clinical Trial Eligibility Overview. Trial Name: NCT04396808 — N/A

Prostate Cancer Research Study Groups: Standard of care (no pre-treatment genomics testing), Standard of care + pre-treatment genomics testing

Prostate Cancer Clinical Trial 2023: Decipher Highlights & Side Effects. Trial Name: NCT04396808 — N/A

Decipher (Gene Expression Classifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04396808 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this clinical investigation?

"Affirmative. Clinicaltrials.gov confirms that this investigation is actively recruiting, which began on November 5th 2020 and was last edited on 11/7/2022. This research needs to acquire 900 patients from 4 distinct clinical sites."

Answered by AI

Is the enrollment for this research project open at present?

"Affirmative. Clinicaltrials.gov highlights that this medical research, initially posted on November 5th 2020, is actively recruiting individuals for participation. Approximately 900 subjects need to be enrolled from 4 different healthcare facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer

2020. "Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04396808.

All > Prostate Cancer High Point