Precision Oncology for Cancer

(PROGRESS Trial)

Overseen By Douglas Kirk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Active concurrent malignancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Precision Oncology Navigation?

Research shows that patient navigation, which is part of Precision Oncology Navigation, helps improve the timing of important cancer care events and increases patient satisfaction by providing support and reducing barriers to treatment. ^{1 2 3 4 5}

Is Precision Oncology for Cancer generally safe for humans?

The research articles discuss various tools and methods to identify and prevent adverse events (unwanted side effects) in cancer treatments, highlighting the importance of patient safety in oncology. While they do not specifically address Precision Oncology for Cancer, they emphasize ongoing efforts to monitor and improve safety in cancer treatments, suggesting a focus on minimizing risks. ^{6 7 8 9 10}

How is the Precision Oncology Navigation treatment different from other cancer treatments?

Precision Oncology Navigation is unique because it uses advanced genetic testing and data analysis to tailor cancer treatment specifically to the genetic makeup of an individual's tumor, unlike traditional treatments that are more generalized. This personalized approach aims to improve treatment effectiveness by targeting the specific mutations present in a patient's cancer. ^{11 12 13 14 15}

Research Team

Carrie Lee

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This trial is for stage IV solid tumor cancer patients, including those with breast, lung, colorectal, and bladder cancers. Participants must be eligible for genomic testing to guide therapy choices.

Inclusion Criteria

Subjects willing and able to comply with study procedures based on the judgment of the investigator

I can take care of myself but might not be able to do heavy physical work.

My doctor plans to use advanced genetic testing for my cancer treatment.

Exclusion Criteria

I have another active cancer besides the one being studied.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and NGS Testing

Participants undergo Next Generation Sequencing (NGS) testing and expert review to facilitate genome-informed therapy (GIT) orders

12 months

Follow-up

Participants are monitored for overall survival and other outcomes after the return of NGS results

2 years

Treatment Details

Interventions

• Precision Oncology Navigation

Trial Overview The study tests if a precision oncology navigator and expert review of next-generation sequencing (NGS) results can increase the use of genome-informed therapies in advanced cancer treatment over historical rates.

Participant Groups

Group I: The potential candidates for genome-informed targeted therapy Experimental Treatment 3 Interventions

Potential candidates have a stage IV solid tumor malignancy (breast, lung, colorectal, and bladder cancer) for whom NGS testing is planned to be obtained before first or second-line therapy.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

Patient navigation (PN) significantly increases patient satisfaction with cancer care according to a randomized controlled trial, showing a large effect size (SMD = 2.30), indicating its potential effectiveness in improving patient experiences.

However, non-randomized studies did not find a significant association between PN and satisfaction, suggesting that the quality of the study design may influence the perceived effectiveness of PN in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of patient navigation on satisfaction with cancer care: a systematic review and meta-analysis. Wells, KJ., Campbell, K., Kumar, A., et al.[2019]

The study developed and validated the Patient Satisfaction with Navigation, Logistical measure, which assesses patient navigation experiences in cancer treatment, using data from 1,873 diverse participants.

The measure demonstrated strong psychometric properties, providing reliable and precise scores for evaluating patient satisfaction with navigation services, which can help improve cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of the patient satisfaction with logistical aspects of navigation (PSN-L) scale using item response theory. Carle, AC., Jean-Pierre, P., Winters, P., et al.[2021]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

In a study of 322,887 cancer patients undergoing treatment, 19% experienced oncology-specific adverse events, with higher rates in those with metastatic cancers (41% for colorectal and 50% for lung cancer).

The most common triggers for these adverse events included abnormal serum bicarbonate levels and blood transfusions, highlighting the need for targeted monitoring in cancer care to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. Weingart, SN., Nelson, J., Koethe, B., et al.[2021]

A new screening tool was developed to identify adverse events (AEs) in cancer care, consisting of 76 specific triggers that can help detect potential safety issues during treatment.

This tool, which categorizes triggers related to general care, vital signs, medications, and laboratory tests, has the potential to improve patient safety and quality of care in oncology, although further testing is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. Lipitz-Snyderman, A., Weingart, SN., Anderson, C., et al.[2021]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of patient navigation on satisfaction with cancer care: a systematic review and meta-analysis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of the patient satisfaction with logistical aspects of navigation (PSN-L) scale using item response theory. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Predictors of resolution in navigated patients with abnormal cancer screening tests. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

The Architecture of a Precision Oncology Platform. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Establishment of a living biobank : Improved guidance of precision cancer care with in vitro and in vivo cancer models]. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Clinical Use of Precision Oncology Decision Support. [2020]

14. England pubmed.ncbi.nlm.nih.gov

PRECISION: the Belgian molecular profiling program of metastatic cancer for clinical decision and treatment assignment. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

An Approach to Solving the Complex Clinicogenomic Data Landscape in Precision Oncology: Learnings From the Design of WAYFIND-R, a Global Precision Oncology Registry. [2022]