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PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with stage IV breast, lung, colon or rectal, or bladder cancer that has spread to other parts of the body. It tests whether help from a cancer care guide and a pharmacist’s review of tumor gene tests leads to more treatment choices based on gene results. It also tracks joining trials based on tumor test results and survival over 2 years.

This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers). The purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1/2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form to join and allow sharing of personal health information.
  • Be willing and able to follow study steps, as judged by the study doctor.
  • Be at least 18 years old when you sign up.
  • Have an ECOG or Karnofsky score of 0–2, as listed in the study. These scores measure how well you can do daily activities.
  • Have confirmed stage IV non-small cell lung, colon or rectal, breast, or bladder cancer.
  • Your care provider thinks tumor gene testing is appropriate and plans to consider the results for your first or second treatment for cancer that has spread.
  • Your tumor gene test has not been ordered yet, or it has been ordered but results are not back.

Who can't join

  • Have another active cancer at the same time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria * Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. * Subjects are willing and able to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at the time of consent. * ECOG or Karnofsky Performance Status of 0-2. * Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer * The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting * A genomic tumor test has not been ordered or has been ordered but not resulted. Exclusion Criteria: • Subjects with an active concurrent malignancy.

Study sites (1)

NC